Methods for enlarging ostia of paranasal sinuses

ABSTRACT

Sinusitis and other disorders of the ear, nose and throat are diagnosed and/or treated using minimally invasive approaches with flexible or rigid instruments. Various methods and devices are used for remodeling or changing the shape, size or configuration of a sinus ostium or duct or other anatomical structure in the ear, nose or throat; implanting a device, cells or tissues; removing matter from the ear, nose or throat; delivering diagnostic or therapeutic substances or performing other diagnostic or therapeutic procedures. Introducing devices (e.g., guide catheters, tubes, guidewires, elongate probes, other elongate members) may be used to facilitate insertion of working devices (e.g. catheters e.g. balloon catheters, guidewires, tissue cutting or remodeling devices, devices for implanting elements like stents, electrosurgical devices, energy emitting devices, devices for delivering diagnostic or therapeutic agents, substance delivery implants, scopes etc.) into the paranasal sinuses or other structures in the ear, nose or throat. Specific devices (e.g., tubular guides, guidewires, balloon catheters, tubular sheaths) are provided as are methods for manufacturing and using such devices to treat disorders of the ear, nose or throat.

RELATED APPLICATION

This application is a continuation of copending U.S. patent applicationSer. No. 11/150,847 entitled “Implantable Devices and Methods forTreating Sinusitis and Other Disorders” filed Jun. 10, 2005, and issuedas U.S. Pat. No. 7,803,150 on Sep. 28, 2010, which is acontinuation-in-part of copending U.S. patent application Ser. No.10/944,270, now abandoned, entitled “Apparatus and Methods for Dilatingand Modifying Ostia of Paranasal Sinuses and Other Intranasal orParanasal Structures” filed on Sep. 17, 2004 which is acontinuation-in-part of Ser. No. 10/829,917 entitled “Devices, Systemsand Methods for Diagnosing and Treating Sinusitis and Other Disorders ofthe Ears, Nose and/or Throat” filed on Apr. 21, 2004, and issued as U.S.Pat. No. 7,654,997 on Feb. 2, 2010, the entire disclosures of suchearlier filed applications being expressly incorporated herein byreference.

FIELD OF THE INVENTION

The present invention relates generally to medical devices and methodsand more particularly to minimally invasive, devices, systems andmethods for treating sinusitis and other ear, nose & throat disorders.

BACKGROUND

The nose is responsible for warming, humidifying and filtering inspiredair and for conserving heat and moisture from expired air. The nose isformed mainly of cartilage, bone, mucous membranes and skin.

The bones in the nose contain a series of cavities known as paranasalsinuses that are connected by passageways. The paranasal sinuses includefrontal sinuses, ethmoid sinuses, sphenoid sinuses and maxillarysinuses. The paranasal sinuses are lined with mucous-producingepithelial tissue and ultimately opening into the nasal cavity.Normally, mucous produced by the epithelial tissue slowly drains out ofeach sinus through an opening known as an ostium. If the epithelialtissue of one of these passageways becomes inflamed for any reason, thecavities which drain through that passageway can become blocked. Thisblockage can be periodic (resulting in episodes of pain) or chronic.This interference with drainage of mucous (e.g., occlusion of a sinusostium) can result in mucosal congestion within the paranasal sinuses.Chronic mucosal congestion of the sinuses can cause damage to theepithelium that lines the sinus with subsequent decreased oxygen tensionand microbial growth (e.g., a sinus infection).

Sinusitis:

The term “sinusitis” refers generally to any inflammation or infectionof the paranasal sinuses caused by bacteria, viruses, fungi (molds),allergies or combinations thereof. It has been estimated that chronicsinusitis (e.g., lasting more than 3 months or so) results in 18 millionto 22 million physician office visits per year in the United States.

Patients who suffer from sinusitis typically experience at least some ofthe following symptoms:

-   -   headaches or facial pain    -   nasal congestion or post-nasal drainage    -   difficulty breathing through one or both nostrils    -   bad breath    -   pain in the upper teeth        Thus, one of the ways to treat sinusitis is by restoring the        lost mucous flow. The initial therapy is drug therapy using        anti-inflammatory agents to reduce the inflammation and        antibiotics to treat the infection. A large number of patients        do not respond to drug therapy. Currently, the gold standard for        patients with chronic sinusitis that do not respond to drug        therapy is a corrective surgery called Functional Endoscopic        Sinus Surgery.        Current and Proposed Procedures for Sinus Treatment:

Functional Endoscopic Sinus Surgery

In FESS, an endoscope is inserted into the nose and, under visualizationthrough the endoscope, the surgeon may remove diseased or hypertrophictissue or bone and may enlarge the ostia of the sinuses to restorenormal drainage of the sinuses. FESS procedures are typically performedwith the patient under general anesthesia.

Although FESS continues to be the gold standard therapy for surgicaltreatment of severe sinus disease, FESS does have several shortcomings.For example, FESS can cause significant post-operative pain. Also, someFESS procedures are associated with significant postoperative bleedingand, as a result, nasal packing is frequently placed in the patient'snose for some period of time following the surgery. Such nasal packingcan be uncomfortable and can interfere with normal breathing, eating,drinking etc. Also, some patients remain symptomatic even after multipleFESS surgeries. Additionally, some FESS procedures are associated withrisks of iatrogenic orbital, intracranial and sinonasal injury. Manyotolaryngologists consider FESS an option only for patients who sufferfrom severe sinus disease (e.g., those showing significant abnormalitiesunder CT scan). Thus, patients with less severe disease may not beconsidered candidates for FESS and may be left with no option but drugtherapy. One of the reasons why FESS procedures can be bloody andpainful relates to the fact that instruments having straight, rigidshafts are used. In order to target deep areas of the anatomy with suchstraight rigid instrumentation, the physician needs to resect and removeor otherwise manipulate any anatomical structures that may lie in thedirect path of the instruments, regardless of whether those anatomicalstructures are part of the pathology.

Balloon Dilation Based Sinus Treatment

Methods and devices for sinus intervention using dilating balloons havebeen disclosed in U.S. Pat. No. 2,525,183 (Robison) and United StatesPatent Publication No. 2004/0064150 A1 (Becker). For example, U.S. Pat.No. 2,525,183 (Robison) discloses an inflatable pressure device whichcan be inserted following sinus surgery and inflated within the sinus.The patent does not disclose device designs and methods for flexiblynavigating through the complex nasal anatomy to access the natural ostiaof the sinuses. The discussion of balloon materials is also fairlylimited to thin flexible materials like rubber which are most likely tobe inadequate for dilating the bony ostia of the sinus.

United States patent publication No. 2004/0064150 A1 (Becker) disclosesballoon catheters formed of a stiff hypotube to be pushed into a sinus.The balloon catheters have a stiff hypotube with a fixed pre-set anglethat enables them to be pushed into the sinus. In at least someprocedures wherein it is desired to position the balloon catheter in theostium of a paranasal sinus, it is necessary to advance the ballooncatheter through complicated or tortuous anatomy in order to properlyposition the balloon catheter within the desired sinus ostium. Also,there is a degree of individual variation in the intranasal andparanasal anatomy of human beings, thus making it difficult to design astiff-shaft balloon catheter that is optimally shaped for use in allindividuals. Indeed, rigid catheters formed of hypotubes that havepre-set angles cannot be easily adjusted by the physician to differentshapes to account for individual variations in the anatomy. In view ofthis, the Becker patent application describes the necessity of havingavailable a set of balloon catheters, each having a particular fixedangle so that the physician can select the appropriate catheter for thepatient's anatomy. The requirement to test multiple disposable cathetersfor fit is likely to be very expensive and impractical. Moreover, ifsuch catheter are disposable items (e.g., not sterilizable and reusable)the need to test and discard a number of catheters before finding onethat has the ideal bend angle could be rather expensive.

Thus, although the prior art discloses the use of dilating balloons forsinus treatments, it does not disclose the various means for navigationthrough the complex anatomy without significant manipulation ofnon-pathogenic anatomical regions that obstruct direct access to thesinus openings. Further, the prior art only discloses balloons ofrelatively simple shapes or materials for dilating sinus openings.Further, this art does not sufficiently elaborate beyond endoscopy onother means for imaging or tracking the position of such devices withinthe sinus anatomy.

Thus, there is a need for new devices and methods for easily navigatingthe complex anatomy of the nasal cavities and paranasal sinuses and fortreating disorders of the paranasal sinuses with minimal complicationsdue to individual variations in anatomy and causing minimal trauma to ordisruption of anatomical structures that are not pathogenic.

SUMMARY OF THE INVENTION

In general, the present invention provides methods, devices and systemsfor diagnosing and/or treating sinusitis or other conditions of the ear,nose or throat.

In accordance with the present invention, there are provided methodswherein one or more flexible or rigid elongate devices as describedherein are inserted in to the nose, nasopharynx, paranasal sinus, middleear or associated anatomical passageways to perform an interventional orsurgical procedure. Examples of procedures that may be performed usingthese flexible catheters or other flexible elongate devices include butare not limited to: remodeling or changing the shape, size orconfiguration of a sinus ostium or other anatomical structure thataffects drainage from one or more paranasal sinuses; cutting, ablating,debulking, cauterizing, heating, freezing, lasing, forming an osteotomyor trephination in or otherwise modifying bony or cartilaginous tissuewithin paranasal sinus or elsewhere within the nose; removing puss oraberrant matter from the paranasal sinus or elsewhere within the nose;scraping or otherwise removing cells that line the interior of aparanasal sinus; delivering contrast medium; delivering atherapeutically effective amount of a therapeutic substance; implantinga stent, tissue remodeling device, substance delivery implant or othertherapeutic apparatus; cutting, ablating, debulking, cauterizing,heating, freezing, lasing, dilating or otherwise modifying tissue suchas nasal polyps, abberant or enlarged tissue, abnormal tissue, etc.;grafting or implanting cells or tissue; reducing, setting, screwing,applying adhesive to, affixing, decompressing or otherwise treating afracture; delivering a gene or gene therapy preparation; removing all ora portion of a tumor; removing a polyp; delivering histamine, anallergen or another substance that causes secretion of mucous by tissueswithin a paranasal sinus to permit assessment of drainage from thesinus; implanting a cochlear implant or indwelling hearing aid oramplification device, etc.

Still further in accordance with the invention, there are provideddevices and systems for performing some or all of the proceduresdescribed herein. Introducing devices may be used to facilitateinsertion of working devices (e.g. catheters e.g. balloon catheters,tissue cutting or remodeling devices, guidewires, devices for implantingelements like stents, electrosurgical devices, energy emitting devices,devices for delivering diagnostic or therapeutic agents, substancedelivery implants, scopes etc) into the paranasal sinuses and otherstructures in the ear, nose or throat.

Still further in accordance with the invention, there are providedapparatus and methods for navigation and imaging of the interventionaldevices within the sinuses using endoscopic including stereo endoscopic,fluoroscopic, ultrasonic, radiofrequency localization, electromagnetic,magnetic and other radiative energy based modalities. These imaging andnavigation technologies may also be referenced by computer directly orindirectly to pre-existing or simultaneously created 3-D or 2-D datasets which help the doctor place the devices within the appropriateregion of the anatomy.

Still further in accordance with the invention, there are providedtubular guides, guidewires, balloon catheters, tubular sheaths andrelated methods for using such devices individually or in variouscombinations to dilate openings of paranasal sinuses (e.g., anytransnasally accessible opening in a paranasal sinus or cranio-facialair cell, including but not limited to; natural ostia, surgically ormedically altered ostia, surgically created or man made openings,antrostomy openings, ostiotomy openings, trephination openings, burrholes, drilled holes, ethmoidectomy openings, anatomical passageways,natural or man made passages, etc.) or other anatomical structures suchas structures within the head or a human or animal subject that comprisebone covered at least in part by mucosal tissue.

Still further in accordance with the invention, there are providedspecific methods and modes of construction for tubular guides,guidewires, balloon catheters, tubular sheaths.

Still further in accordance with the invention, there are providedmethods for accessing (e.g., advancing a catheter, guide or other deviceto) openings of paranasal sinuses (e.g., any transnasally accessibleopening in a paranasal sinus or cranio-facial air cell, including butnot limited to; natural ostia, surgically or medically altered ostia,surgically created or man made openings, antrostomy openings, ostiotomyopenings, trephination openings, burr holes, drilled holes,ethmoidectomy openings, anatomical passageways, natural or man madepassages, etc.) or other anatomical structures within the body of ahuman or animal subject even though such openings or structures may befully or partially hidden from direct or endoscopic view.

Further aspects, details and embodiments of the present invention willbe understood by those of skill in the art upon reading the followingdetailed description of the invention and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a schematic diagram of a system for catheter-basedminimally invasive sinus surgery of the present invention being used toperform a sinus surgery procedure on a human patient.

FIG. 1A is an enlarged view of portion “1A” of FIG. 1.

FIGS. 2A through 2D are partial sagittal sectional views through a humanhead showing various steps of a method for gaining access to a paranasalsinus using a guide and thereafter dilating or remodeling the ostialopening into the paranasal sinus.

FIGS. 2E through 2H are partial sagittal sectional views through a humanhead showing various steps of a method for gaining access to a paranasalsinus using a steerable guide and thereafter.

FIGS. 2I through 2L are partial sagittal sectional views through a humanhead showing various steps of a method for gaining access to a paranasalsinus using an introducing device in the form of a guidewire with apreset shape.

FIGS. 2M through 2O are partial sagittal sectional views through a humanhead showing various steps of a method for gaining access to a paranasalsinus using a balloon catheter that has a guide protruding from itsdistal end.

FIGS. 2P through 2X are partial sagittal sectional views through a humanhead showing various steps of a method of accessing an ethmoid sinusthrough a natural or artificially created opening of the ethmoid sinus.

FIGS. 2Y through 2AC are partial coronal sectional views through a humanhead showing various steps of a method for treating a mucocele in afrontal sinus.

FIGS. 3A through 3C are partial coronal sectional views through a humanhead showing various steps of a method of accessing a paranasal sinusthrough an artificially created opening of the paranasal sinus.

FIG. 4A shows a partial longitudinal sectional view of a system fordilating a sinus ostium or other intranasal anatomical structure, suchsystem comprising three progressively larger dilators useable insequence.

FIGS. 4B through 4E show various steps of a method of dilating a nasalcavity using a working device comprising a balloon catheter with apressure-expandable stent.

FIG. 4F shows a partial perspective view of a working device thatcomprises a side suction and/or side cutter.

FIG. 4G shows a partial perspective view of a working device thatcomprises a rotating cutter to cut away tissue.

FIGS. 4H and 4I show various steps of a method of dilating the ostium ofa paranasal sinus or other nasal passageway using a mechanical dilator.

FIGS. 4J and 4K show perspective views of a mechanical dilatorcomprising a screw mechanism.

FIGS. 4L and 4M show sectional views of a mechanical dilator thatcomprises a pushable member.

FIGS. 4N and 4O show sectional views of a mechanical dilator thatcomprises a pullable member.

FIGS. 4P and 4Q show sectional views of a mechanical dilator thatcomprises a hinged member.

FIGS. 4R through 4W′ are schematic diagrams of alternativeconfigurations for the distal portions of mechanical dilators of thetypes shown in FIGS. 4H through 4Q.

FIG. 5A shows a perspective view of a balloon that comprises a conicalproximal portion, a conical distal portion and a cylindrical portionbetween the conical proximal portion and the conical distal portion.

FIG. 5B shows a perspective view of a conical balloon.

FIG. 5C shows a perspective view of a spherical balloon.

FIG. 5D shows a perspective view of a conical/square long balloon.

FIG. 5E shows a perspective view of a long spherical balloon.

FIG. 5F shows a perspective view of a bi-lobed “dog bone” balloon.

FIG. 5G shows a perspective view of an offset balloon.

FIG. 5H shows a perspective view of a square balloon.

FIG. 5I shows a perspective view of a conical/square balloon.

FIG. 5J shows a perspective view of a conical/spherical long balloon.

FIG. 5K shows a perspective view of an embodiment of a tapered balloon.

FIG. 5L shows a perspective view of a stepped balloon.

FIG. 5M shows a perspective view of a conical/offset balloon.

FIG. 5N shows a perspective view of a curved balloon.

FIG. 5O shows a partial perspective view of a balloon catheter devicecomprising a balloon for delivering diagnostic or therapeuticsubstances.

FIG. 5P shows a partial perspective view of a balloon/cutter catheterdevice comprising a balloon with one or more cutter blades.

FIG. 5Q shows a perspective view of a balloon catheter device comprisinga balloon with a reinforcing braid attached on the external surface ofthe balloon.

FIG. 5R shows a partial sectional view of a balloon catheter whereininflation ports are located near the distal end of the balloon.

FIG. 5S shows a partial sectional view of an embodiment of a ballooncatheter comprising multiple balloons inflated by a single lumen.

FIG. 5T shows a partial sectional view of a balloon catheter comprisingmultiple balloons inflated by multiple lumens.

FIGS. 5U through 5AB show perspective and sectional views of variousembodiments of balloon catheters having sensors mounted thereon ortherein.

FIG. 6A shows a partial perspective view of a shaft design useable inthe various devices disclosed herein, wherein the shaft comprises anexternal spiral wire.

FIG. 6B shows a partial perspective view of a shaft design for thevarious devices disclosed herein, wherein the shaft comprises astiffening wire.

FIG. 6C shows a partial perspective view of an embodiment of a shaftdesign for the various devices disclosed herein, wherein the shaftcomprises stiffening rings.

FIG. 6D shows a partial perspective view of a shaft design for thevarious devices disclosed herein, wherein the shaft comprisescontrollable stiffening elements.

FIG. 6E shows a partial perspective view of a shaft design for thevarious devices disclosed herein, wherein the shaft comprises ahypotube.

FIG. 6F shows a partial perspective cut-away view of a shaft design forthe various devices disclosed herein, wherein the shaft comprises abraid.

FIG. 6F′ is an enlarged side view of the braid of the device of FIG. 6F.

FIG. 6G shows a partial perspective view of an embodiment of a devicecomprising a shaft having a plastically deformable region.

FIG. 6H shows a partial perspective view of a device comprising a shafthaving a flexible element.

FIG. 6I shows a partial perspective view of a shaft comprising amalleable element.

FIG. 6J shows a partial perspective view of the shaft of FIG. 6I in abent configuration.

FIG. 6K shows a cross sectional view through plane 6K-6K of FIG. 6I.

FIG. 6L shows a partial sectional view of an embodiment of acontrollably deformable-shaft.

FIG. 6M shows a partial sectional view of the controllably deformableshaft of FIG. 6L in a deformed state.

FIG. 6N shows a perspective view of a balloon catheter comprising arigid or semi-rigid member.

FIGS. 6O through 6Q show sectional views of a balloon catheter thatcomprises an insertable and removable element.

FIG. 7A shows a cross sectional view through a balloon catheter shaftcomprising two cylindrical lumens.

FIG. 7B shows a cross sectional view through a balloon catheter shaftcomprising an inner lumen and an annular outer lumen disposed about theinner lumen.

FIG. 7C shows a cross sectional view through a balloon catheter shaftwhich comprises a first tubular element with a first lumen, a secondtubular element with a second lumen and a jacket surrounding the firstand second tubular elements.

FIG. 7D shows a cross sectional view through a balloon catheter shaftcomprising three lumens.

FIG. 7E shows a cross sectional view through a balloon catheter shaftcomprising a cylindrical element, a tubular element that has a lumen anda jacket surrounding the cylindrical element and the tubular element.

FIG. 7F shows a cross sectional view of through a balloon catheter shaftcomprising an embedded braid.

FIG. 7G shows a partial perspective view of a catheter shaft comprisinga zipper lumen with a guide extending through a portion of the zipperlumen.

FIG. 7H shows a cross sectional view through line 7H-7H of FIG. 7G. FIG.7I shows is a partial longitudinal sectional view of a catheter shaftcomprising a rapid exchange lumen with a guide extending through therapid exchange lumen.

FIG. 7J shows a cross sectional view of the catheter shaft of FIG. 7Ithrough line 7J-7J.

FIG. 7K shows a cross sectional view of the catheter shaft of FIG. 7Ithrough line 7K-7K.

FIG. 7L is a partial perspective view of a balloon catheter device ofthe present invention comprising a through-lumen and a balloon inflationlumen within the shaft of the catheter.

FIG. 7M is a cross sectional view through line 7M-7M of FIG. 7L.

FIG. 7N is a cross sectional view through line 7N-7N of FIG. 7L.

FIG. 7O is a partial perspective view of another balloon catheter deviceof the present invention comprising a through lumen within the shaft ofthe catheter and a balloon inflation tube disposed next to andoptionally attached to the catheter shaft.

FIG. 7P is a cross sectional view through line 7P-7P of FIG. 7O.

FIG. 7Q is a cross sectional view through line 7Q-7Q of FIG. 7O.

FIG. 8A shows a partial perspective view of a catheter shaft comprisingdistance markers.

FIG. 8B shows a partial perspective view of a catheter shaft comprisingone type of radiopaque markers.

FIG. 8C shows a partial perspective view of a catheter shaft comprisinganother type of radiopaque markers.

FIG. 8D shows a partial perspective view of a balloon cathetercomprising an array of radiopaque markers arranged on the outer surfaceof the balloon.

FIG. 8E shows a partial perspective view of a balloon cathetercomprising an array of radiopaque markers arranged on an inner surfaceof the balloon.

FIG. 8E′ is a longitudinal sectional view of FIG. 8E.

FIG. 9A is a side view of a tubular guide device of the presentinvention.

FIG. 9B is a side view of a guidewire of the present invention.

FIG. 9C is a side view of a tubular sheath of the present invention.

FIG. 9D is a side view of a balloon catheter of the present invention.

FIG. 10A is a side view of a tubular guide device of the presentinvention having a straight distal portion.

FIG. 10B is a side view of a tubular guide device of the presentinvention having a 30 degree curve in its distal portion.

FIG. 10B′ is an enlarged view of the distal end of the tubular guidedevice of FIG. 10B.

FIG. 10C is a side view of a tubular guide device of the presentinvention having a 70 degree curve in its distal portion.

FIG. 10C′ is an enlarged view of the distal end of the tubular guidedevice of FIG. 10C.

FIG. 10D is a side view of a tubular guide device of the presentinvention having a 90 degree curve in its distal portion.

FIG. 10D′ is an enlarged view of the distal end of the tubular guidedevice of FIG. 10D.

FIG. 10E is a side view of a tubular guide device of the presentinvention having a 110 degree curve in its distal portion.

FIG. 10E′ is an enlarged view of the distal end of the tubular guidedevice of FIG. 10E.

FIG. 10F is a sectional view of the distal end of an embodiment of atubular guide device of the present invention.

FIG. 10G is a sectional view of the distal end of another embodiment ofa tubular guide device of the present invention.

FIG. 11 is a perspective view of a tubular guide device of the presentinvention.

FIG. 11A is a cross sectional view through line 11A-11A of FIG. 11.

FIG. 11B is a cross sectional view through line 11B-11B of FIG. 11.

FIG. 11C is a cross sectional view through line 11C-11C of FIG. 11.

FIG. 11C′ shows an enlarged view of region 11C′ in FIG. 11C

FIG. 12 is a longitudinal sectional view of a guidewire device of thepresent invention.

FIG. 13 A is a perspective view of an embodiment of a tubular sheath ofthe present invention,

FIG. 13B is a perspective view of another embodiment of a tubular sheathof the present invention.

FIG. 14 is a side view of a balloon catheter device of the presentinvention.

FIG. 14A is a cross sectional view through line 14A-14A of FIG. 14.

FIG. 14B is a cross sectional view through line 14B-14B of FIG. 14.

FIG. 14C is an enlarged view of segment 14C of FIG. 14.

FIG. 14D is an enlarged view of segment 14D of FIG. 14.

FIG. 14E is a cross sectional view through line 14E-14E of FIG. 14C.

DETAILED DESCRIPTION

The following detailed description, the accompanying drawings and theabove-set-forth Brief Description of the Drawings are intended todescribe some, but not necessarily all, examples or embodiments of theinvention. The contents of this detailed description do not limit thescope of the invention in any way.

A number of the drawings in this patent application show anatomicalstructures of the ear, nose and throat. In general, these anatomicalstructures are labeled with the following reference letters:

Nasal Cavity NC Nasopharynx NP Frontal Sinus FS Ethmoid Sinus ES EthmoidAir Cells EAC Sphenoid Sinus SS Sphenoid Sinus Ostium SSO MaxillarySinus MS Mucocele MC

FIGS. 1 and 1A provide a general showing of a minimally invasive surgerysystem of the present invention comprising a C-arm fluoroscope 1000 thatis useable to visualize a first introducing device 1002 (e.g., a guidecatheter or guide tube), a second introducing device 1004 (e.g., aguidewire or elongate probe) and a working device 1006 (e.g., a ballooncatheter, other dilation catheter, debrider, cutter, etc.). FIGS. 2A-8E′show certain non-limiting examples of the introducing devices 1002(e.g., a guide catheter or guide tube), 1004 (guides, guidewires,elongate probes, etc.) and working devices 1006 (e.g., a ballooncatheters, other dilation catheters, debrider, cutters, etc.) that maybe useable in accordance with this invention. The devices 1002, 1004,1006 may be radiopaque and/or may incorporate radiopaque markers suchthat C-arm fluoroscope 1000 may be used to image and monitor thepositioning of the devices 1002, 1004, 1006 during the procedure. Inaddition to or, as an alternative to the use of radiographic imaging,the devices 1002, 1004, 1006 may incorporate and/or may be used inconjunction with one or more endoscopic devices, such as the typicalrigid or flexible endoscopes or stereo endocscopes used byotolaryngologists during FESS procedures. Also, in addition to or as analternative to radiographic imaging and/or endoscopic visualizations,some embodiments of the devices 1002, 1004, 1006 may incorporate sensorswhich enable the devices 1002, 1004, 1006 to be used in conjunction withimage guided surgery systems or other electro-anatomicalmapping/guidance systems including but not limited to: VectorVision(BrainLAB AG); HipNav (CASurgica); CBYON Suite (CBYON); InstaTrak,FluoroTrak, ENTrak (GE Medical); StealthStation Treon, iOn (Medtronic);Medivision; Navitrack (Orthosoft); OTS (Radionics); VISLAN (Siemens);Stryker Navigation System (Stryker Leibinger); Voyager, Z-Box (Z-KatInc.) and NOGA and CARTO systems (Johnson & Johnson). Commerciallyavailable interventional navigation systems can also be used inconjunction with the devices and methods. Further non-fluoroscopicinterventional imaging technologies including but not limited to:OrthoPilot (B. Braun Aesculap); PoleStar (Odin Medical Technologies;marketed by Medtronic); SonoDoppler, SonoWand (MISON); CT Guide, USGuide (UltraGuide) etc. may also be used in conjunction with the devicesand methods. Guidance under magnetic resonance is also feasible if thecatheter is modified to interact with the system appropriately.

It is to be appreciated that the devices and methods of the presentinvention relate to the accessing and dilation or modification of sinusostia or other passageways within the ear nose and throat. These devicesand methods may be used alone or may be used in conjunction with othersurgical or non-surgical treatments, including but not limited to thedelivery or implantation of devices and drugs or other substances asdescribed in copending U.S. patent application Ser. No. 10/912,578entitled Implantable Devices and Methods for Delivering Drugs and OtherSubstances to Treat Sinusitis and Other Disorders filed on Aug. 4, 2004,the entire disclosure of which is expressly incorporated herein byreference.

FIGS. 2A through 2D are partial sagittal sectional views through a humanhead showing various steps of a method of gaining access to a paranasalsinus using a guide catheter. In FIG. 2A, a first introducing device inthe form of a guide catheter 200 is introduced through a nostril andthrough a nasal cavity NC to a location close to an ostium SSO of asphenoid sinus SS. The guide catheter 200 may be flexible. Flexibledevices are defined as devices with a flexural stiffness less than about200 pound-force per inch over a device length of one inch. The guidecatheter 200 may be straight or it may incorporate one or more preformedcurves or bends. In embodiments where the guide catheter 200 is curvedor bent, the deflection angle of the curve or bend may be in the rangeof up to 135°. Examples of specific deflection angles formed by thecurved or bent regions of the guide catheter 200 are 0°, 30°, 45°, 60°,70°, 90°, 120° and 135°. Guide catheter 200 can be constructed fromsuitable elements like Pebax, Polyimide, Braided Polyimide,Polyurethane, Nylon, PVC, Hytrel, HDPE, PEEK, metals like stainlesssteel and fluoropolymers like PTFE, PFA, FEP and EPTFE. Guide catheter200 can have a variety of surface coatings e.g. hydrophilic lubriciouscoatings, hydrophobic lubricious coatings, abrasion resisting coatings,puncture resisting coatings, electrically or thermal conductivecoatings, radiopaque coatings, echogenic coatings, thrombogenicityreducing coatings and coatings that release drugs. In FIG. 2B, a secondintroduction device comprising a guidewire 202 is introduced through thefirst introduction device (i.e., the guide catheter 200) so that theguidewire 202 enters the sphenoid sinus SS through the ostium SSO.Guidewire 202 may be constructed and coated as is common in the art ofcardiology. In FIG. 2C, a working device 204 for example a ballooncatheter is introduced over guidewire 202 into the sphenoid sinus SS.Thereafter, in FIG. 2D, the working device 204 is used to perform adiagnostic or therapeutic procedure. In this particular example, theprocedure is dilation of the sphenoid sinus ostium SSO, as is evidentfrom FIG. 2D. However, it will be appreciated that the present inventionmay also be used to dilate or modify any sinus ostium or other man-madeor naturally occurring anatomical opening or passageway within the nose,paranasal sinuses, nasopharynx or adjacent areas. After the completionof the procedure, guide catheter 200, guidewire 202 and working device204 are withdrawn and removed. As will be appreciated by those of skillin the art, in this or any of the procedures described in this patentapplication, the operator may additionally advance other types ofcatheters or of the present invention, a guidewire 202 may be steerable(e.g. torquable, actively deformable) or shapeable or malleable.Guidewire 202 may comprise an embedded endoscope or other navigation orimaging modalities including but not limited to fluoroscopic, X-rayradiographic, ultrasonic, radiofrequency localization, electromagnetic,magnetic, robotic and other radiative energy based modalities. In thisregard, some of the figures show optional scopes SC is dotted lines. Itis to be appreciated that such optional scopes SC may comprise anysuitable types of rigid or flexible endoscopes and such optional scopesSC may be separate from or incorporated into the working devices and/orintroduction devices of the present invention.

FIGS. 2E through 2H are partial sagittal sectional views through a humanhead showing various steps of a method of gaining access to a paranasalsinus using a steerable catheter. In FIG. 2E, an introducing device inthe form of a steerable catheter 206 is introduced through a nostril.Although commercially available devices are neither designed, nor easilyusable for this technique in the sinuses, examples of a device which hasa steerable tip with functionality similar to that described hereinclude but are not limited to the Naviport™ manufactured by Cardima,Inc. in Fremont, Calif.; Attain Prevail and Attain Deflectable cathetersmanufactured by Medtronic; Livewire Steerable Catheters manufactured bySt. Jude Medical Inc.; Inquiry™ Steerable Diagnostic Cathetersmanufactured by Boston Scientific; TargetCath™ manufactured by EBI;Safe-Steer Catheter manufactured by Intraluminal Therapeutics, Inc.;Cynosar manufactured by Catheter Research, Inc.; Torque Control BalloonCatheter manufactured by Cordis Corp. and DynamicDeca Steerable Catheterand Dynamic XT Steerable Catheter manufactured by A.M.I. TechnologiesLtd, Israel. Steerable catheter 206 comprises a proximal portion, adistal portion and a controllably deformable region between the proximalportion and the distal portion. In FIG. 2F, the steerable catheter 206is steered through the nasal anatomy so that the distal portion ofsteerable catheter 206 is near an ostium SSO of a sphenoid sinus SS. InFIG. 2G, a working device in the form of a balloon catheter 208 isintroduced through steerable catheter 206 so that it enters sphenoidsinus SS through the ostium SSO. Thereafter, balloon catheter 208 isadjusted so that the balloon of the balloon catheter is located in theostium SSO. In FIG. 2H, balloon catheter 208 is used to dilate theostium SSO. After completion of the procedure, steerable catheter 206and balloon catheter 208 are withdrawn from the nasal anatomy. In thisexample, only a first introduction device in the form of a steerablecatheter 206 is used to effect insertion and operative positioning ofthe working device (which in this example is balloon catheter 208). Itwill be appreciated, however, in some procedures, a second introductiondevice (e.g., an elongate guide member, guidewire, elongate probe, etc.)could be advanced through the lumen of the steerable catheter 206 andthe working device 208 could then be advanced over such secondintroduction device to the desired operative location.

FIGS. 2I through 2L are partial sagittal sectional views through a humanhead showing various steps of a method for gaining access to a paranasalsinus using an introducing device in the form of a guidewire with apreset shape. In FIG. 2I, an introducing device in the form of aguidewire 210 with a preset shape is introduced in a nasal cavity.Guidewire 210 comprises a proximal portion and a distal portion and isshaped such that it can easily navigate through the nasal anatomy. Inone embodiment, guidewire 210 is substantially straight. In anotherembodiment, guidewire 210 comprises an angled, curved or bent regionbetween the proximal portion and the distal portion. Examples of thedeflection angle of the angled, curved or bent regions are 0°, 30°, 45°,60°, 70°, 90°, 120° and 135°. In FIG. 2J, guidewire 210 is advancedthrough the nasal anatomy so that the distal tip of guidewire enters asphenoid sinus SS through an ostium SSO. In FIG. 2K, a working device inthe form of a balloon catheter 212 is advanced along guidewire 210 intothe sphenoid sinus SS. Typically, as described more fully herebelow, theworking device will have a guidewire lumen extending through or formedin or on at least a portion of the working device 212 to facilitateadvancement of the working device 212 over the guidewire 212 in themanner well understood in the art of interventional medicine.Thereafter, the position of balloon catheter 212 is adjusted so that theballoon of the balloon catheter is located in the ostium SSO. Asdescribed elsewhere in this application, the balloon catheter 212 may beradiopaque and/or may incorporate one or more visible or imageablemarkers or sensors. In FIG. 2L, balloon catheter 212 is used to dilatethe ostium SSO. After completion of the procedure, guidewire 210 andballoon catheter 212 are withdrawn from the nasal anatomy. In oneembodiment, balloon catheter 212 is shapeable or malleable.

FIGS. 2M through 2O are partial sagittal sectional views through a humanhead showing various steps of a method of gaining access to a paranasalsinus using a balloon catheter comprising a steering wire at its distalend. In FIG. 2M, a working device comprising a balloon catheter 214comprising a proximal portion and distal portion is introduced in anasal cavity. Balloon catheter 214 comprises a steering wire 216 at itsdistal end. In FIG. 2N, balloon catheter 214 is advanced through thenasal anatomy into a sphenoid sinus SS through a sphenoid sinus ostiumSSO. Thereafter, the position of balloon catheter 214 is adjusted sothat the balloon of the balloon catheter is located in the ostium SSO.In FIG. 2O, balloon catheter 214 is used to dilate the ostium SSO. Aftercompletion of the procedure, balloon catheter 214 is withdrawn from thenasal anatomy. In one embodiment, steering wire 216 can be retractedinto or advanced from balloon catheter 214. The retraction oradvancement of steering wire can be controlled by several means like athumb wheel, a slide, a button hooked up to electronic motor and atrigger. In another embodiment, steering wire 216 may be hollow or mayincorporate one or more lumen(s) to enable it to introduce or removedevices or diagnostic or therapeutic agents, examples of which aredescribed in copending U.S. patent application Ser. No. 10/912,578entitled Implantable Devices and Methods for Delivering Drugs and OtherSubstances to Treat Sinusitis and Other Disorders filed on Aug. 4, 2004,the entire disclosure of which is expressly incorporated herein byreference.

FIGS. 2P through 2X are partial sagittal sectional views through a humanhead showing various steps of a method for accessing an ethmoid sinusthrough a natural or artificially created opening of the ethmoid sinus.In FIG. 2P, an introducing device in the form of a guide catheter 218 isintroduced in an ethmoid sinus ES. Ethmoid sinus ES comprises multipleethmoid air cells EAC. In FIG. 2Q, a guidewire 220 is introduced throughguide catheter into a first EAC. Thereafter, in FIG. 2R, a ballooncatheter 222 is introduced over guidewire 220 into the first EAC. InFIG. 2S, balloon catheter 222 is inflated to dilate the structures ofES. In FIG. 2T, guide catheter 218, guidewire 220 and balloon catheter222 are withdrawn leaving a first new passage in the ES. The newlycreated passage in the ES facilitates drainage of the mucous through theES. Alternatively, in FIG. 2U, only balloon catheter 222 is withdrawn.The position of guide catheter 218 is adjusted and guidewire 220 isintroduced into a second EAC. In FIG. 2V, balloon catheter 222 isintroduced over guidewire 220 into the second EAC. In FIG. 2W, ballooncatheter 222 is inflated to dilate the structures of ES. In FIG. 2X,guide catheter 218, guidewire 220 and balloon catheter 222 are withdrawnleaving a second new passage in the ES. The second new passage in the ESfurther facilitates drainage of the mucous through the ES. This methodof dilating the structures of ES can be repeated to create multiple newpassages in the ES.

FIGS. 2Y through 2AC are partial coronal sectional views through a humanhead showing various steps of a method for treating a mucocele in afrontal sinus. In FIG. 2Y, an introducing device in the form of a guidecatheter 224 is introduced in a frontal sinus FS through the nasalcavity NC. Frontal sinus FS has a mucocele MC to be treated. In FIG. 2Z,a penetrating device 226 comprising a sharp tip 228 is introducedthrough guide catheter 224 such that penetrating device 226 puncturesthe MC at least partially. In FIG. 2AA, a balloon catheter 230 isintroduced over penetrating device 226 into the MC. Thereafter, in FIG.2AB, balloon catheter 230 is inflated to rupture the MC and allow thedrainage of contents of the MC. In FIG. 2AC, penetrating device 226 andballoon catheter 230 are withdrawn.

The methods disclosed herein may also comprise the step of cleaning orlavaging anatomy within the nose, paranasal sinus, nasopharynx or nearbystructures including but not limited to irrigating and suctioning. Thestep of cleaning the target anatomy can be performed before or after adiagnostic or therapeutic procedure.

The methods of the present invention may also include one or morepreparatory steps for preparing the nose, paranasal sinus, nasopharynxor nearby structures for the procedure, such as spraying or ravagingwith a vasoconstricting agent (e.g., 0.025-0.5% phenylephyrine orOxymetazoline hydrochloride (Neosynephrine or Afrin) to cause shrinkageof the nasal tissues, an antibacterial agent (e.g., provodine iodine(Betadine), etc. to cleanse the tissues, etc.

FIGS. 3A through 3C are partial coronal sectional views through a humanhead showing various steps of a method of accessing a paranasal sinusthrough an artificially created opening of the paranasal sinus. In FIG.3A, a puncturing device 300 is inserted through a nostril and used tocreate an artificial opening in a maxillary sinus. There are severalpuncturing devices well known in the art like needles including needles,needles with bent shafts, dissectors, punches, drills, corers, scalpels,burs, scissors, forceps and cutters. In FIG. 3B, puncturing device 300is withdrawn and a working device for example a balloon catheter 302 isintroduced through the artificial opening into the maxillary sinus. InFIG. 3C, balloon catheter 302 is used to dilate the artificially createdopening in the maxillary sinus. After this step, the balloon catheter302 is withdrawn. It will be appreciated that, in some embodiments, thepuncturing device 300 may have a lumen through which an introductiondevice (e.g., a guidewire or other elongate probe or member), may beinserted into the maxillary sinus and the puncturing device 300 may thenbe removed leaving such introduction device (e.g., a guidewire or otherelongate probe or member) in place. In such cases, the working device(e.g., balloon catheter 302) may incorporate a lumen or other structurethat allows the working device (e.g., balloon catheter 300) to beadvanced over the previously inserted introduction device (e.g., aguidewire or other elongate probe or member).

In the methods illustrated so far, balloon catheters were used only asan example for the several alternate working devices that could be usedwith this invention. FIG. 4A shows a sectional view of an example of aworking device comprising a set of three sequential dilators: a firstsequential dilator 402, a second sequential dilator 404 and a thirdsequential dilator 406. The D₃ of third sequential dilator 406 isgreater than the diameter D₂ of second sequential dilator 404 which inturn is greater than the diameter D₁ of first sequential dilator 402.The sequential dilators may comprise one or more bent or angled regions.The sequential dilators can be constructed from a variety ofbiocompatible materials like stainless steel 316. A variety of othermetals, polymers and materials can also be used to construct thesequential dilators.

FIGS. 4B through 4E show various steps of a method of dilating a nasalcavity using a working device comprising a balloon catheter with apressure-expandable stent. In FIG. 4B, an introducing device e.g. aguidewire 416 is introduced into a nasal cavity e.g. an ostium of asinus. In FIG. 4C, a balloon catheter 418 is introduced over guidewire416 into the nasal cavity. Balloon catheter 418 comprises apressure-expandable stent 420. The position of balloon catheter 418 isadjusted so that pressure-expandable stent 420 is located substantiallywithin the target anatomy where the stent is to be deployed. In FIG. 4D,the balloon of balloon catheter 418 is expanded to deploypressure-expandable stent 420. In FIG. 4E, balloon catheter 418 iswithdrawn leaving pressure-expandable stent 420 in the nasal cavity.Several types of stent designs can be used to construct stent 420 likemetallic tube designs, polymeric tube designs, chain-linked designs,spiral designs, rolled sheet designs, single wire designs etc. Thesedesigns may have an open celled or closed celled structure. A variety offabrication methods can be used for fabricating stent 420 including butnot limited to laser cutting a metal or polymer element, welding metalelements etc. A variety of materials can be used for fabricating stent420 including but not limited to metals, polymers, foam type materials,plastically deformable materials, super elastic materials etc. Somenon-limiting examples of materials that can be used to construct thestent are silicones e.g. silastic, polyurethane, gelfilm andpolyethylene. A variety of features can be added to stent 420 includingbut not limited to radiopaque coatings, drug elution mechanisms etc.

FIG. 4F shows a partial perspective view of an embodiment of a workingdevice comprising a side suction and/or cutting device 422 comprising adevice body 424 having a side opening 426. Cutting device 422 isadvanced into a passageway such as a nostril, nasal cavity, meatus,ostium, interior of a sinus, etc. and positioned so that side opening426 is adjacent to matter (e.g., a polyp, lesion, piece of debris,tissue, blood clot, etc.) that is to be removed. Cutting device 422 isrotated to cut tissue that has been positioned in the side opening 426.Cutting device 422 may incorporate a deflectable tip or a curved distalend which may force side opening 426 against the tissue of interest.Further, this cutting device 422 may have an optional stabilizingballoon incorporated on one side of cutting device 422 to press itagainst the tissue of interest and may also contain one or more on-boardimaging modalities such as ultrasound, fiber or digital optics, OCT, RFor electro-magnetic sensors or emitters, etc.

FIG. 4G shows a partial perspective view of an embodiment of a workingdevice comprising a rotating cutter device to cut away tissue. Rotatingcutter device 428 comprises a rotating member 430 enclosed in anintroducing device 432. Rotating member 430 comprises a rotating blade434 located near the distal region of rotating member 430. Rotatingblade 434 may be retractable into rotating member 430. Rotating cutterdevice 428 is inserted in a passageway 436 such as a nostril, nasalcavity, meatus, ostium, interior of a sinus, etc. and positioned so thatrotating blade 434 is adjacent to matter (e.g., a polyp, lesion, pieceof debris, tissue, blood clot, etc.) that is to be removed. Thereafter,rotating member 430 is rotated to cause rotating blade 434 to removetissue. In one embodiment, rotating member 430 can be retracted intointroducing device 432. In another embodiment, rotating cutter device428 may comprise a mechanism for suction or irrigation near the distalend of rotating cutter device 428.

FIGS. 4H and 4I show various steps of a method of dilating a nasalcavity using a working device comprising a mechanical dilator 408.Mechanical dilator 408 comprises an outer member 410, an inner member412 and one or more elongate bendable members 414. Inner member 412 canslide within outer member 410. The proximal ends of bendable members 414are attached to distal end of outer member 410 and the distal ends ofbendable members 414 are attached to distal end of inner member 412. InFIG. 4H, mechanical dilator 408 is inserted into an opening in the nasalanatomy e.g. an ostium of a sinus. Mechanical dilator 408 is positionedin the opening such that bendable members 414 are within the opening inthe nasal anatomy. In FIG. 4I, relative motion of outer member 410 andinner member 412 causes the distal end of outer member 410 to comecloser to the distal end of inner member 412. This causes bendablemembers 414 to bend such that the diameter of the distal region ofmechanical dilator 408 increases. This causes bendable members 414 tocome into contact with the opening in the nasal anatomy and exert anoutward pressure to dilate the opening. Various components of mechanicaldilator 408 like outer member 410, inner member 412 and bendable members414 can be constructed from suitable biocompatible materials likestainless steel 316. A variety of other metals, polymers and materialscan also be used to construct the various components of mechanicaldilator 408. In one embodiment, outer member 410 is substantially rigidand inner member 412 is flexible. Outer member 410 can be substantiallystraight or may comprise one or more bent or angled regions. Innermember 412 may comprise one or more lumens.

FIGS. 4J and 4K illustrate a perspective view of a design of amechanical dilator comprising a screw mechanism. FIG. 4J shows themechanical dilator comprising an outer member 438 and an inner screwmember 440. Inner screw member 440 is connected to outer member 438through a first pivot 442 located on the distal end of outer member 438.The distal end of inner screw member 440 is connected to a second pivot444. The mechanical dilator further comprises one or more bendablemembers 446. The distal end of bendable members 446 is attached tosecond pivot 444 and the proximal end of bendable members 446 isattached to fist pivot 442. In FIG. 4K, inner screw member 440 isrotated in one direction. This causes second pivot 444 to come closer tofirst pivot 442. This causes bendable members 446 to bend in the radialdirection exerting an outward radial force. This force can be used todilate or displace portions of the anatomy. Outer member 438 can besubstantially straight or may comprise one or more bent or angledregions. Inner screw member 440 may comprise one or more lumens.

FIGS. 4L and 4M illustrate sectional views of a design of a mechanicaldilator comprising a pushable member. FIG. 4L shows the mechanicaldilator comprising an outer member 448 comprising one or more bendableregions 449 on the distal end of outer member 448. Mechanical dilatorfurther comprises an inner pushable member 450 comprising an enlargedregion 452 on the distal end of inner pushable member 450. In FIG. 4M,inner pushable member 450 is pushed in the distal direction. This exertsan outward force on bendable regions 449 causing bendable regions 449 tobend in a radial direction exerting an outward force. This force can beused to dilate or displace portions of the anatomy. Outer member 448 canbe substantially straight or may comprise one or more bent or angledregions. Inner pushable member 450 may comprise one or more lumens.

FIGS. 4N and 4O illustrate sectional views of a design of a mechanicaldilator comprising a pullable member. FIG. 4N shows the mechanicaldilator comprising an outer member 454 comprising one or more bendableregions 456 on the distal end of outer member 454. Mechanical dilatorfurther comprises an inner pullable member 458 comprising an enlargedregion 460 on the distal end of inner pullable member 458. In FIG. 4O,inner pullable member 458 is pulled in the proximal direction. Thisexerts an outward force on bendable regions 456 causing bendable regions456 to bend in a radial direction exerting an outward force. This forcecan be used to dilate or displace portions of the anatomy. Outer member454 can be substantially straight or may comprise one or more bent orangled regions. Inner pullable member 458 may comprise one or morelumens.

FIGS. 4P and 4Q illustrate sectional views of a design of a mechanicaldilator comprising a hinged member. FIG. 4P shows the mechanical dilatorcomprising an outer member 462 comprising one or more bendable regions464 located on the distal end of outer member 462. The mechanicaldilator also comprises an inner member 466 located within outer member462. In one embodiment, inner member 466 is tubular. The distal end ofinner member 466 comprises one or more first hinges 468. First hinges468 are hinged to the proximal ends of one or more moving elements 470.Distal ends of moving elements 470 are hinged to one or more secondhinges 472 located on the inner surface of outer member 462. In FIG. 4Q,inner member 466 is pushed in the distal direction. This causes movingelements 470 to exert an outward radial force on bendable regions 464causing bendable regions 464 to bend in an outward radial direction withan outward force. This outward force can be used to dilate or displaceportions of the anatomy. Outer member 462 can be substantially straightor may comprise one or more bent or angled regions. Inner member 466 maycomprise one or more lumens.

FIGS. 4R through 4W illustrate examples of configurations of mechanicaldilators in FIGS. 4H through 4Q. FIG. 4R shows a sectional view of amechanical dilator comprising an inner member 474, an outer stationarymember 476 and an outer bendable member 478. In FIG. 4S, movement ofinner member 474 displaces outer bendable member 478 in the radialdirection with a force. This force can be used to dilate or displaceportions of the anatomy. This configuration is useful to exert force ina particular radial direction. FIG. 4S′ shows a partial perspective viewof the outer stationary member 476 of FIG. 4R. FIG. 4T shows a sectionalview of a mechanical dilator comprising an inner member 480, a firstouter hemi-tubular member 482 and a second outer hemi-tubular member484. In FIG. 4U, movement of inner member 480 displaces first outerhemi-tubular member 482 and second outer hemi-tubular member 484 in theradial direction with a force. This force can be used to dilate ordisplace portions of the anatomy. This configuration is useful to exertforce in two diametrically opposite regions. FIG. 4U′ shows a partialperspective view of the first outer hemi-tubular member 482 and thesecond outer hemi-tubular member 484 of FIG. 4T. FIG. 4V shows asectional view of a mechanical dilator comprising an inner member 486, afirst outer curved member 488 and a second outer curved member 490. InFIG. 4W, movement of inner member 486 displaces first outer curvedmember 488 and second outer curved member 490 in the radial directionwith a force. This force can be used to dilate or displace portions ofthe anatomy. This configuration is useful to exert force over smallerareas in two diametrically opposite regions. FIG. 4W′ shows a partialperspective view of the first outer curved member 488 and the secondouter curved member 490 of FIG. 4V. Similar designs for mechanicaldilators in FIGS. 4H through 4Q are possible using three or moredisplaceable members. The inner member in the mechanical dilatorsdisclosed herein may be replaced by a balloon for displacing the outermembers to exert an outward radial force.

Several other designs of the working device may also be used includingbut not limited to cutters, chompers, rotating drills, rotating blades,tapered dilators, punches, dissectors, burs, non-inflating mechanicallyexpandable members, high frequency mechanical vibrators, radiofrequencyablation devices, microwave ablation devices, laser devices (e.g. CO2,Argon, potassium titanyl phosphate, Holmium:YAG and Nd:YAG laserdevices), snares, biopsy tools, scopes and devices that introducediagnostic or therapeutic agents.

FIG. 5A shows a perspective view of an embodiment of a ballooncomprising a conical proximal portion, a conical distal portion and acylindrical portion between the conical proximal portion and the conicaldistal portion. FIGS. 5B to 5N show perspective views of severalalternate embodiments of the balloon. FIG. 5B shows a conical balloon,FIG. 5C shows a spherical balloon, FIG. 5D shows a conical/square longballoon, FIG. 5E shows a long spherical balloon, FIG. 5F shows a dogbone balloon, FIG. 5G shows a offset balloon, FIG. 5H shows a squareballoon, FIG. 5I shows a conical/square balloon, FIG. 5J shows aconical/spherical long balloon, FIG. 5K shows a tapered balloon, FIG. 5Lshows a stepped balloon, FIG. 5M shows a conical/offset balloon and FIG.5N shows a curved balloon.

The balloons disclosed herein can be fabricated from biocompatiblematerials including but not limited to polyethylene terephthalate,Nylon, polyurethane, polyvinyl chloride, crosslinked polyethylene,polyolefins, HPTFE, HPE, HDPE, LDPE, EPTFE, block copolymers, latex andsilicone. The balloons disclosed herein can be fabricated by a varietyof fabrication methods including but not limited to molding, blowmolding, dipping, extruding etc.

The balloons disclosed herein can be inflated with a variety ofinflation media including but not limited to saline, water, air,radiographic contrast materials, diagnostic or therapeutic substances,ultrasound echogenic materials and fluids that conduct heat, cold orelectricity.

The balloons in this invention can also be modified to deliverdiagnostic or therapeutic substances to the target anatomy. For example,FIG. 5O shows a partial perspective view of an embodiment of a ballooncatheter device 500 comprising a balloon for delivering diagnostic ortherapeutic substances. Balloon catheter device 500 comprises a flexiblecatheter 502 having a balloon 504 thereon. The catheter device 500 isadvanced, with balloon 504 deflated, into a passageway such as anostril, nasal cavity, meatus, ostium, interior of a sinus, etc. andpositioned with the deflated balloon 504 situated within an ostium,passageway or adjacent to tissue or matter that is to be dilated,expanded or compressed (e.g., to apply pressure for hemostasis, etc.).Thereafter, the balloon 504 may be inflated to dilate, expand orcompress the ostium, passageway, tissue or matter. Thereafter theballoon 504 may be deflated and the device 500 may be removed. Thisballoon 504 may also be coated, impregnated or otherwise provided with amedicament or substance that will elute from the balloon into theadjacent tissue (e.g., bathing the adjacent tissue with drug orradiating the tissue with thermal or other energy to shrink the tissuesin contact with the balloon 504). Alternatively, in some embodiments,the balloon may have a plurality of apertures or openings through whicha substance may be delivered, sometimes under pressure, to cause thesubstance to bathe or diffuse into the tissues adjacent to the balloon.Alternatively, in some embodiments, radioactive seeds, threads, ribbons,gas or liquid, etc. may be advanced into the catheter shaft 502 orballoon 504 or a completely separate catheter body for some period oftime to expose the adjacent tissue and to achieve a desired diagnosticor therapeutic effect (e.g. tissue shrinkage, etc.).

The balloons in this invention can have a variety of surface features toenhance the diagnostic or therapeutic effects of a procedure. Forexample, FIG. 5P shows a partial perspective view of an embodiment of aballoon/cutter catheter device 506 comprising a flexible catheter 508having a balloon 510 with one or more cutter blades 512 formed thereon.The device 506 is advanced, with balloon 510 deflated, into a passagewaysuch as a nostril, nasal cavity, meatus, ostium, interior of a sinus,etc. and positioned with the deflated balloon 510 situated within anostium, passageway or adjacent to tissue or matter that is to bedilated, expanded or compressed and in which it is desired to make oneor more cuts or scores (e.g. to control the fracturing of tissue duringexpansion and minimize tissue trauma etc.). Thereafter, the balloon 510is inflated to dilate, expand or compress the ostium, passageway, tissueor matter and causing the cutter blade(s) 512 to make cut(s) in theadjacent tissue or matter. Thereafter the balloon 510 is deflated andthe device 506 is removed. The blade may be energized with mono orbi-polar RF energy or otherwise heated such that it will cut the tissueswhile also causing hemostasis and/or to cause thermal contraction ofcollagen fibers or other connective tissue proteins, remodeling orsoftening of cartilage, etc.

The balloons in this invention can have a variety of reinforcing meansto enhance the balloon properties. For example, FIGS. 5Q and 5Q′ showperspective views of an embodiment of a balloon catheter device 514comprising a flexible catheter 516 having a balloon 518 with one or morereinforcing means 520 thereon. In this example, reinforcing means 520 isa braid attached on the external surface of balloon 518. The reinforcingbraid can be constructed from suitable materials like polymer filaments(e.g. PET or Kevlar filaments), metallic filaments (e.g. SS316 orNitinol filaments) and metallic or non-metallic meshes or sheets. Avariety of other reinforcing means can be used including but not limitedto reinforcing coatings, external or internal reinforcing coils,reinforcing fabric, reinforcing meshes and reinforcing wires,reinforcing rings, filaments embedded in balloon materials etc. FIG. 5Q″shows a perspective view of a reinforcing braid that can be used withthe balloon catheter device in FIGS. 5Q and 5Q′.

The balloons in this invention can have a variety of inflation means toenhance the balloon properties. FIG. 5R shows a partial sectional viewof an embodiment of a balloon catheter 522 comprising a shaft 524 and aballoon 526. Shaft 524 comprises a balloon inflation lumen. The distalportion of balloon inflation lumen terminates in inflation ports 528located near the distal end of balloon 526. Thus, when balloon catheter522 is inserted in an orifice and balloon 526 is inflated, the distalportion of balloon 526 inflates earlier than the proximal portion ofballoon 526. This prevents balloon 526 from slipping back out of theorifice.

FIGS. 5S through 5T illustrate designs of balloon catheters comprisingmultiple balloons. FIG. 5S shows a partial sectional view of anembodiment of a balloon catheter 530 comprising a shaft 532 with a lumen533. Lumen 533 opens into three orifices located on shaft 532 namely afirst orifice 534, a second orifice 536 and a third orifice 538. Thethree orifices are used to inflate three balloons. First orifice 534inflates a first balloon 540, second orifice 536 inflates a secondballoon 542 and third orifice 538 inflates third balloon 544. In oneembodiment, first balloon 540 and third balloon 544 are inflated with asingle lumen and second balloon 542 is inflated with a different lumen.In another embodiment, first balloon 540, second balloon 542 and thirdballoon 544 interconnected and are inflated with a single lumen. A valvemechanism allows first balloon and second balloon to inflate beforeallowing second balloon to inflate.

Alternatively, the balloons can be inflated by separate lumens. FIG. 5Tshows a partial sectional view of an embodiment of a balloon catheter546 comprising a shaft 548 comprising a first inflation lumen 550, asecond inflation lumen 552 and a third inflation lumen 554. The threeinflation lumens are used to inflate three non-connected balloons. Firstinflation lumen 550 inflates a first balloon 556, second inflation lumen552 inflates a second balloon 558 and third inflation lumen 554 inflatesa third balloon 560.

The devices disclosed herein may comprise one or more navigation orvisualization modalities. FIGS. 5U through 5AB illustrate perspectiveand sectional views of various embodiments of a balloon cathetercomprising sensors. FIG. 5U shows a partial perspective view of aballoon catheter comprising an outer member 562, an inner member 564 anda balloon 566 attached to distal region of outer member 562 and distalregion of inner member 564. The balloon catheter further comprises afirst sensor 568 located on the distal region of outer member 562 and asecond sensor 570 located on the distal region of inner member 564. FIG.5V shows a cross section through plane 5V-5V in FIG. 5U. Outer member562 comprises a first sensor lumen 572 to receive the lead from firstsensor 568. Inner member 564 comprises a second sensor lumen 574 toreceive the lead from second sensor 570. Inner member 564 furthercomprises a circular lumen 576. Outer member 562 and inner member 564enclose an annular lumen 578. In one embodiment, annular lumen 578 is aballoon inflation lumen.

FIG. 5W shows a partial perspective view of a balloon cathetercomprising an outer member 580, an inner member 582 and a balloon 584attached to distal region of outer member 580 and distal region of innermember 582. The balloon catheter further comprises a first sensor 586located on the distal region of inner member 582 and a second sensor 588located on the distal region of inner member 582 distal to first sensor586. FIG. 5X shows a cross section through plane 5X-5X in FIG. 5W. Innermember 582 comprises a first sensor lumen 590 to receive the lead fromfirst sensor 586 and a second sensor lumen 592 to receive the lead fromsecond sensor 588. Inner member 582 further comprises a circular lumen594. Outer member 580 and inner member 582 enclose an annular lumen 596.In one embodiment, annular lumen 596 is a balloon inflation lumen.

FIG. 5Y shows a partial perspective view of a balloon cathetercomprising an outer member 598, an inner member 600 and a balloon 602attached to distal region of outer member 598 and distal region of innermember 600. The balloon catheter further comprises a first sensor 604located on the distal region of outer member 598 and a second sensor 606located on the distal region of outer member 598 distal to first sensor604. FIG. 5Z shows a cross section through plane 5Z-5Z in FIG. 5Y. Outermember 598 comprises a first sensor lumen 608 to receive the lead fromfirst sensor 604 and a second sensor lumen 610 to receive the lead fromsecond sensor 606. Inner member 600 comprises a circular lumen 612.Outer member 598 and inner member 600 enclose an annular lumen 614. Inone embodiment, annular lumen 614 is a balloon inflation lumen.

The leads from the sensors may be attached on the surface of an elementof the balloon catheter without being enclosed in a lumen. FIG. 5AAshows a partial perspective view of a balloon catheter comprising anouter member 616, an inner member 618 and a balloon 620 attached todistal region of outer member 616 and distal region of inner member 618.The balloon catheter further comprises a first sensor 624 located on thedistal region of outer member 616 and a second sensor 626 located on thedistal region of inner member 618. Second sensor 626 comprises a lead628. FIG. 5AB shows a cross section through plane 5AB-5AB in FIG. 5M.Outer member 616 comprises a first sensor lumen 630 to receive the leadfrom first sensor 624. Inner member 618 comprises a circular lumen 632.Lead 628 from second sensor 626 is attached on the outer surface ofinner member 618 and is oriented parallel to inner member 618. Outermember 616 and inner member 618 enclose an annular lumen 634. In oneembodiment, annular lumen 634 is a balloon inflation lumen. The sensorsmentioned in FIGS. 5U through 5AB can be electromagnetic sensors orsensors including but not limited to location sensors, magnetic sensors,electromagnetic coils, RF transmitters, mini-transponders, ultrasoundsensitive or emitting crystals, wire-matrices, micro-silicon chips,fiber-optic sensors, etc.

FIGS. 6A through 6G illustrate partial perspective views of severalembodiments of shaft designs for the various devices disclosed herein.These shaft designs are especially useful for devices that encounterhigh torque or high burst pressures or require enhanced pushability,steerability and kink resistance. FIG. 6A shows a partial perspectiveview of an embodiment of a shaft 602 comprising a spiral element 604wound around the shaft. Spiral element 604 can be made of suitablematerials like metals (e.g. SS316L, SS304) and polymers. In oneembodiment, spiral element 604 is in the form of round wire of diameterbetween 0.04 mm to 0.25 mm. In another embodiment, spiral element is inthe form of flat wire of cross section dimensions ranging from 0.03mm×0.08 mm to 0.08 mm×0.25 mm. FIG. 6B shows a partial perspective viewof an embodiment of a shaft 606 comprising a reinforcing filament 608.Reinforcing filament 608 is substantially parallel to the axis of shaft606. Shaft 606 with reinforcing filament 608 can be covered with ajacketing layer. Reinforcing filament 608 can be made of suitablematerials like metals, polymers, glass fiber etc. Reinforcing filament608 can also have shape memory characteristics. In one embodiment,reinforcing filament 608 is embedded in shaft 606. In anotherembodiment, reinforcing filament is introduced through a lumen in shaft606. Shaft 606 may comprise more than one reinforcing filament 608. FIG.6C shows a partial perspective view of an embodiment of a shaft 610comprising one of more stiffening rings 612 along the length of shaft610. FIG. 6D shows a partial perspective view of an embodiment of ashaft 614 comprising a series of controllably stiffening elements 616along the length of the shaft. Shaft 614 further comprises a tensionwire 618 that runs through controllably stiffening elements 616 and isattached to the most distal stiffening element. The tension in tensionwire 618 causes controllably stiffening elements 616 to come intocontact with each other with a force. Friction between controllablystiffening elements 616 causes shaft 614 to have a certain stiffness.Increasing the tension in tension wire 618 increases the force withwhich controllably stiffening elements 616 come into contact with eachother. This increases the friction between controllably stiffeningelements 616 which in turn increases the stiffness of shaft 614.Similarly, reducing the tension in tension wire 618 reduces thestiffness of shaft 614. Controllably stiffening elements 616 can be madefrom suitable materials like metal, polymers and composites. In oneembodiment, controllably stiffening elements 616 are separated from eachother by one or more springs. Tension wire 618 can be made from metalslike SS316. Tension wire 618 may also be used to cause the device toactively bend or shorten in response to tension. FIG. 6E shows a partialperspective view of an embodiment of a shaft 620 comprising a hypotube622. In one embodiment, hypotube 622 is located on the exterior surfaceof shaft 620. In another embodiment, hypotube 622 is embedded in shaft620. Hypotube 620 can be made of metals like stainless steel 316 orsuitable polymers. FIGS. 6F and 6F′ show a partial perspective view ofan embodiment of a shaft 624 comprising a reinforcing element 626 in theform of a reinforcing braid or mesh located on the outer surface ofshaft 624. Reinforcing element 626 can be made of suitable materialslike polymer filaments (e.g. PET or Kevlar filaments), metallic wirese.g. SS316 wires etc. The braid pattern can be regular braid pattern,diamond braid pattern, diamond braid pattern with a half load etc. Inone embodiment, the outer surface of reinforcing element 626 is coveredwith a jacketing layer.

The shafts of various devices disclosed herein may be non homogenousalong their length. Examples of such shafts are illustrated in FIGS. 6Gthrough 6H. FIG. 6G shows a partial perspective view of an embodiment ofa device comprising a shaft 628 comprising a proximal portion 630, adistal portion 632, a working element 634 and a plastically deformableregion 636 located between the proximal portion 630 and distal portion632. Plastically deformable region 636 can be deformed by a physician toadjust the angle between proximal portion 630 and distal portion 632.This enables the devices to be used for several different anatomicalregions of the same patient. Also, such devices can be adjusted foroptimal navigation through a patient's anatomy. In one embodiment, shaft628 comprises multiple plastically deformable regions. In anotherembodiment plastically deformable region 636 is located within workingelement 634. Such a design comprising one or more plastically deformableregions can be used for any of the devices mentioned herein likecatheters with working elements, guide catheters, guide catheters with apre-set shape, steerable guide catheters, steerable catheters,guidewires, guidewires with a pre-set shape, steerable guidewires,ports, introducers, sheaths etc.

FIG. 6H shows a partial perspective view of an embodiment of a devicecomprising a shaft with a flexible element. The design is illustrated asa shaft 638 comprising a proximal portion 640, a distal portion 642 anda working element 644 (e.g. a balloon). Shaft 638 further comprises aflexible element 646 located between proximal portion 640 and distalportion 642. This design enables proximal portion 640 to bend withrespect to distal portion 642 making it easier to navigate through thecomplex anatomy and deliver working element 644 to the desired location.In one embodiment, shaft 638 comprises multiple flexible elements. Inanother embodiment, flexible element 646 is located within workingelement 644. Such a design comprising one or more flexible elements canbe used for any of the devices mentioned herein like catheters withworking elements, guide catheters, guide catheters with a pre-set shape,steerable guide catheters, steerable catheters, guidewires, guidewireswith a pre-set shape, steerable guidewires, ports, introducers, sheathsetc.

FIGS. 6I through 6K illustrate an example of a shaft comprising amalleable element. FIG. 6I shows a partial perspective view of anembodiment of a shaft 648 comprising malleable element 650 and a lumen652 wherein shaft 648 is in a substantially straight configuration.Malleable element 650 is embedded in shaft 648 such that the axis ofmalleable element 650 is substantially parallel to the axis of shaft648. FIG. 6J shows a partial perspective view of the embodiment of FIG.6I in a bent configuration. FIG. 6K shows a cross sectional view throughplane 6K-6K of FIG. 6I showing shaft 648 comprising malleable element650 and a lumen 652. In one embodiment, shaft 648 comprises more thanone malleable element.

FIGS. 6L through 6M show an embodiment of a controllably deformableshaft. FIG. 6L shows a partial sectional view of an embodiment of acontrollably deformable shaft 654 comprising a pull wire 656 attached toa pull wire terminator 658 located near the distal end of shaft 654.FIG. 6M shows a partial sectional view of the controllably deformableshaft 654 of FIG. 6L in a bent orientation when pull wire 656 is pulledin the proximal direction. The deformation can be varied by varying thelocation of pull wire terminator 658 and the stiffness of varioussections of shaft 658. The stiffness of a section of shaft 658 can bevaried by adding reinforcing coatings, external or internal reinforcingcoils, reinforcing fabric, reinforcing meshes and reinforcing wires,hinged elements, embedded filaments, reinforcing rings etc.

FIG. 6N shows a perspective view of a balloon catheter comprising arigid or semi-rigid member. The balloon catheter comprises a rigid orsemi-rigid member 660 and a balloon 662 located on the distal region ofrigid or semi-rigid member 660. Rigid or semi-rigid member 660 maycomprise one or more lumens. Rigid or semi-rigid member 660 may compriseone or more bent, curved or angled regions. Balloon 662 is inflated by aballoon inflation tube 664 comprising a hub 666 at the proximal end ofballoon inflation tube 664. In one embodiment, balloon inflation tube664 is fully attached along its length to rigid or semi-rigid member660. In another embodiment, balloon inflation tube 664 is partiallyattached along its length to rigid or semi-rigid member 660.

FIGS. 6O through 6Q illustrate sectional views of a balloon cathetercomprising an insertable and removable element. FIG. 6O shows a ballooncatheter 668 comprising a balloon 670, a first lumen 672 and a ballooninflation lumen 674 opening into balloon 670 through an inflation port676. FIG. 6P shows an insertable element 678 having a proximal end 680and a distal end 682. In one embodiment, distal end 682 ends in a sharptip for penetrating tissue. In one embodiment, insertable element 678comprises one or more bent, angled or curved regions 684. Insertableelement 678 can be fabricated from a variety of materials to obtainproperties including but not limited to rigidity, shape memory,elasticity, ability to be plastically deformed etc. In FIG. 6Q,insertable element 678 is inserted into balloon catheter 668 throughfirst lumen 672. This combination can be used to perform a diagnostic ortherapeutic procedure. Insertable element 678 may be removed during orafter the procedure.

FIGS. 7A through 7K show cross sectional views of several embodiments oflumen orientation in the devices disclosed herein. FIG. 7A shows a crosssectional view of an embodiment of a shaft 702 comprising a first lumen704 and a second lumen 706. In one embodiment, first lumen 704 is aguidewire lumen and second lumen 706 is an inflation lumen. FIG. 7Bshows a cross sectional view of an embodiment of a shaft 708 comprisinga first lumen 710 and a annular second lumen 712 such that secondannular lumen 712 is substantially coaxial with first lumen 710. In oneembodiment, first lumen 710 is a guidewire lumen and annular secondlumen 712 is an inflation lumen. FIG. 7C shows a cross sectional view ofan embodiment of a shaft 714 comprising a first tubular element 716comprising a first lumen 718, a second tubular element 720 comprising asecond lumen 722 and a jacket 724 surrounding first tubular element 716and second tubular element 720. In one embodiment, first lumen 718 is aguidewire lumen and second lumen 722 is an inflation lumen. FIG. 7Dshows a cross sectional view of an embodiment of a shaft 726 comprisinga first lumen 728, a second lumen 730 and a third lumen 732. In oneembodiment, first lumen 728 is a guidewire lumen, second lumen 730 is anirrigation/aspiration lumen and third lumen 732 is an inflation lumen.FIG. 7E shows a cross sectional view of an embodiment of a shaft 734comprising a cylindrical element 736, a tubular element 738 comprising alumen 740 and a jacket 742 surrounding cylindrical element 736 andtubular element 738. FIG. 7F shows a cross sectional view of anembodiment of a shaft 744 comprising a tubular member 746 comprising afirst lumen 748 and a second lumen 750; a first coating 752 located onthe outer surface of tubular member 746; a braid 754 located on theouter surface of first coating 752 and a second coating 756 surroundingbraid 754. First lumen 748 is lined with a suitable coating 758 likehydrophilic lubricious coating, hydrophobic lubricious coating, abrasionresisting coating etc. In one embodiment, first lumen 748 is a guidewirelumen and second lumen 750 is an inflation lumen. The lumens disclosedherein can be lined with suitable coatings like hydrophilic lubriciouscoatings, hydrophobic lubricious coatings, abrasion resisting coatings,radiopaque coatings, echogenic coatings etc.

FIG. 7G shows a partial perspective view of an embodiment of a shaft754* comprising a first lumen 756* and a zipper lumen 758*. Zipper lumen758* allows a device like a guidewire 760* to be easily introduced intoor removed from shaft 754*. FIG. 7H shows a cross sectional view throughplane 7H-7H in FIG. 7G showing the orientations of first lumen 756* andzipper lumen 758*.

FIG. 7I shows a cross sectional view of an embodiment of a shaft 762comprising a first lumen 764 and a rapid exchange lumen 766. Rapidexchange lumen 766 extends from the distal end of shaft 762 to aproximal region. Rapid exchange lumen 766 enables shaft 762 to be easilyand quickly introduced or removed over an exchange device like aguidewire 768. FIG. 7J shows a cross sectional view through plane 7J-7Jin FIG. 7I showing first lumen 764 and rapid exchange lumen 766. FIG. 7Kshows a cross sectional view through plane 7K-7K in FIG. 7I showingfirst lumen 764.

FIGS. 7L through 7Q shows perspective and sectional views of lumens forthe devices disclosed herein that are not present throughout the lengthof the devices. FIG. 7L shows a perspective view of a balloon cathetercomprising a shaft 770, a balloon 772 and a lumen 774 that is presentthroughout shaft 770. The balloon catheter further comprises a ballooninflation lumen 776 that opens into balloon 772. The distal end ofballoon inflation lumen 776 is plugged with a plug 778. FIG. 7M shows across section through plane 7M-7M in FIG. 7L showing shaft 770comprising lumen 774 and balloon inflation lumen 776. FIG. 7N shows across section through plane 7N-7N in FIG. 7L showing shaft 770comprising lumen 774 and plug 778. FIG. 7O shows a perspective view of aballoon catheter comprising a shaft 780, a balloon 782 and a lumen 786that is present throughout shaft 780. The balloon catheter furthercomprises a balloon inflation lumen 784. The distal end of ballooninflation lumen 784 opens into balloon 782. FIG. 7P shows a crosssection through plane 7P-7P in FIG. 7O showing shaft 780 comprisinglumen 786 and balloon inflation lumen 784. FIG. 7Q shows a cross sectionthrough plane 7Q-7Q in FIG. 7O showing shaft 780 comprising lumen 786.

FIGS. 8A through 8E show partial perspective views of severalembodiments of markers that may be present on the elements of thedevices mentioned herein. FIG. 8A shows a partial perspective view of anembodiment of a shaft 800 comprising a plurality of distance markers 802located along the length of shaft 800. FIG. 8B shows a partialperspective view of an embodiment of a shaft 804 comprising a pluralityof radiographic markers 806 located along the length of shaft 804. FIG.8C shows a partial perspective view of an embodiment of a shaft 808comprising a plurality of ring shaped radiographic markers 810 locatedalong the length of shaft 808. FIG. 8D shows a partial perspective viewof an embodiment of a balloon catheter 812 comprising a shaft 814 and aballoon 816. Balloon 816 comprises a plurality of radiographic markers818 located on the outer surface of the balloon 816. Such markers 818may be in a linear arrangement, non-linear arrangement or any otherconfiguration that performs the desired marking function (e.g.,delineating the length and/or diameter of the balloon, marking theproximal and/or distal ends of the balloon, etc.). FIGS. 8E and 8E′ showpartial perspective and longitudinal sectional views of an embodiment ofa balloon catheter 820 comprising a shaft 822 and a balloon 824. Balloon824 comprises a plurality of radiographic markers 826 located on theinner surface of the balloon 824. Such markers 826 may be in a lineararrangement, non-linear arrangement or any other configuration thatperforms the desired marking function (e.g., delineating the lengthand/or diameter of the balloon, marking the proximal and/or distal endsof the balloon, etc.). The devices disclosed herein may also compriseseveral other types of markers like ultrasound markers, radiofrequencymarkers and magnetic markers. Similarly, the devices disclosed hereinmay also comprise one or more sensors like electromagnetic sensors,electrical sensors, magnetic sensors, light sensors and ultrasoundsensors.

FIGS. 9A-9D show components that may be used alone or in variouscombinations to perform transnasal procedures within paranasal sinusesand/or within openings (e.g., any transnasally accessible opening in aparanasal sinus or air cell including but not limited to; natural ostia,surgically altered natural ostia, surgically created openings,antrostomy openings, ostiotomy openings, burr holes, drilled holes,ethmoidectomy openings, natural or man made passageways, etc.) inparanasal sinuses. These devices may be sold or used separately ortogether (e.g., as a system or kit).

FIG. 9A shows a side view of a guide device 900 that comprises anelongate tube 902. Elongate tube 902 may be made of suitablebiocompatible material(s) such polymers (e.g. Nylon, elastomericpolyether block amide (PEBAX), etc. The distal portion of elongate tube902 may comprise a bent, angled or curved region. The inner surface ofelongate tube 902 may be lined by a lubricious coating or a tubularlubricious liner. Such a lubricious coating or tubular lubricious lineris useful to facilitate passage of one or more devices through the lumenof guide device 900 especially when guide device 900 comprises anangled, curved or bent region. The distal portion of elongate tube 902may comprise an atraumatic tip 904. Atraumatic tip 904 may be made ofsuitable biocompatible materials such as Pebax, etc. Atraumatic tip 904prevents or reduces damage to the anatomy caused by the distal end ofguide device 900. Guide device 900 further comprises a stiffeningelement e.g. a hypotube 906. Hypotube 906 may be made of suitablebiocompatible materials such as stainless steel, titanium,nickel-titanium alloys (e.g., Nitinol), polymers such as Nylon etc. Inone embodiment, guide device 900 further comprises an outer cover. Theouter cover may be made of Nylon or other thermoplastic material. Theouter cover substantially surrounds the outer surface of hypotube 906and a region of elongate tube 902 emerging from the distal end ofhypotube 906. This embodiment comprising an outer cover is especiallyuseful for providing an outer lubricious surface on guide device 900.This embodiment comprising an outer cover is also useful for improvingjoint integrity between hypotube 906 and elongate tube 902. Thisembodiment comprising an outer cover is also useful for creating asmooth transition between the distal portion of elongate tube 902 andthe distal end of hypotube 906. The proximal end of guide device 900comprises a hub 908. In one embodiment, hub 908 is a female luer hub.The length of the portion of the guide device 900 that enters the bodymay range preferably from 2 inches to 6 inches, and the length of theportion that remains outside of the body is preferably at least 0.5inches. Guide device 900 may be used for introducing one or more devicesinto the anatomy. Guide device 900 may also be used for applying suctionto or providing lavage to an anatomical region. Proximal portion ofguide device 900 may comprise a rotating valve device such as aTouhy-Borst device to lock down a device such as a sheath, guidewire,balloon catheter or other devices that are being inserted through guidedevice 900. Similarly, a Touhy-Borst device may be present on theproximal end of one or more devices disclosed herein. The distal regionof guide device 900 or any other guide device disclosed herein maycomprise a radiopaque marker such as a metal, polymer loaded with aradiopaque substance, etc. In one embodiment, multiple guide devices 900of varying designs are provided in the system shown in FIGS. 9A through9D. The system shown in FIGS. 9A through 9D may comprise more than oneguide device.

FIG. 9B shows a side view of a guidewire 910. The outer diameter ofguidewire 910 is preferably greater than 0.020 inches. In oneembodiment, the outer diameter of guidewire 910 is 0.035 inches.Guidewire 910 comprises a proximal portion 912 and a distal portion 914.Distal portion 914 may comprise a substantially floppy tip. Stiffness ofguidewire 910 may vary along the length of guidewire 910. In oneembodiment, guidewire 910 comprises a lubricious coating made ofmaterials such as polytetrafluoroethylene (PTFE). Guidewire 910 maycomprise one or more radiopaque markers. The outer diameter of guidewire910 is designed to enable passage of guidewire 910 through the ballooncatheter shown in FIG. 9D. In one embodiment, outer diameter ofguidewire 910 is 0.035 inches. Guidewire 910 can be used to introduceone or more devices into the anatomy. The system shown in FIGS. 9Athrough 9D may comprise more than one guidewire.

FIG. 9C shows a side view of a tubular sheath device 920 of the presentinvention. Sheath device 920 comprises an elongate tube 922 that may bemade of any suitable biocompatible material(s) including, but notlimited to polyethylene, elastomeric polyether block amide (PEBAX), etc.In one embodiment, elongate tube 922 may comprise a composite structuretube with lubricious inner liner, stainless steel braid or coil and apolymer jacket. The distal end of elongate tube 922 may comprise anatraumatic tip 924 that prevents or reduces damage to the anatomy causedby the distal end of elongate tube 922. The atraumatic tip may be madeof a soft polymer or may be comprise an atraumatic, rounded distal end.The distal portion of elongate tube 922 comprises a navigation markersuch as a radiopaque marker band 926. In one embodiment, radiopaquemarker band 926 is made of a platinum-iridium alloy. The proximal end ofelongate tube 922 comprises a hub 928. In one embodiment, hub 928 is afemale luer hub. A portion of strain relief tubing 930 may be providedbetween hub 928 and elongate tube 922. In one embodiment, the proximalportion of sheath device 920 comprises a rotating hemostasis valvedevice such as a Touhy-Borst device to lock down a guidewire beingintroduced through sheath device 920. This enables sheath device 920 andthe guidewire to be controlled as one unit. Sheath device 920 may beused for exchanging guidewires, lavage or suction of anatomical regionsetc. Sheath device 920 may also be used to redirect guide wires duringguide wire probing. Other uses of sheath device 920 include, but are notlimited to, introduction and support of various interventional anddiagnostic devices when performing procedures such as sinus ostiadilation, sinus lavage, and suction. Sheath device 920 may also be usedto perform other diagnostic or therapeutic procedures including, but notlimited to treatment of middle ear diseases or disorders via theEustachian tube. The system shown in FIGS. 9A through 9D may comprisemore than one sheath device.

FIG. 9D shows a side view of a balloon catheter. Balloon catheter 934comprises an elongate shaft 936. Elongate shaft 936 may be made fromsuitable biocompatible polymers including, but not limited to Nylon,Pebax, polyethylene, etc. Distal portion of elongate shaft 936 maycomprise one or more radiopaque marker bands. The catheter also has onemarker on the proximal shaft which indicates approximately the exit ofthe balloon proximal bond from the distal end of the guiding catheter.Elongate shaft 936 comprises a balloon inflation lumen for inflating ordeflating a balloon 938 located on the distal portion of elongate shaft936. Balloon 938 may be a compliant or non-compliant balloon. Balloon938 is designed to provide an inflatable segment of known diameter andlength at recommended inflation pressures. In one embodiment, balloon938 is a non-compliant balloon made of PET. In one embodiment, elongateshaft 936 further comprises a guidewire lumen. The guidewire lumen maybe coaxial to the balloon inflation lumen. The guidewire lumen may bevariously designed to enable passage of one or more guidewires such asguidewire 910 may be inserted through the guidewire lumen. In analternate embodiment, balloon catheter 934 comprises a fixed guidewire940 such that the distal end of fixed guidewire 940 forms the distal endof balloon catheter 934. Fixed guidewire 940 may be used for navigationballoon catheter 934 through the anatomy. In the embodiment of ballooncatheter 934 shown in FIG. 9D, the proximal end of balloon cathetercomprises a ‘Y’ connector 942. The proximal end of ‘Y’ connector 942comprises a first luer port 944 that leads to a guidewire lumen inballoon catheter 934. In one embodiment, the region of guide devicearound first luer port 944 comprises a rotating hemostasis valve devicesuch as a Touhy-Borst device to lock down a guidewire being introducedthrough first luer port 944. This enables balloon catheter 934 andguidewire 910 to be controlled as one unit. ‘Y’ connector 942 furthercomprises a second luer port 946 that is in fluid communication with theballoon inflation lumen in balloon catheter 934. Balloon 938 is inflatedby injecting a suitable inflation medium such as diluted contrastsolution through second luer port 946. In one embodiment, proximalportion of elongate shaft 936 comprises a visual marker. The visualmarker is used to verify relative location of balloon 938 relative todistal end of guide device 900 when balloon catheter 934 is usedintroduced through guide device 900. The visual marker completely entersproximal end of guide device 900 when material of balloon 938 completelyexits the distal end of guide device 900. Thus, erroneous inflation ofballoon 938 within guide device 900 can be prevented. Balloon catheter934 can be used to dilate anatomical regions such as ostia and spaceswithin the paranasal sinus cavities for diagnostic and therapeuticprocedures. The system shown in FIGS. 9A through 9D may comprise morethan one balloon catheter.

The system in FIGS. 9A through 9D can be used to treat anatomicalregions such as paranasal sinuses, ostia or passageways leading toparanasal sinuses, etc. In one embodiment of a method of treatingsinusitis by dilating an opening in a paranasal sinus, a suitable guidedevice 900 is inserted through the nose. Guide device 900 is thenadvanced such that the distal end of guide device 900 is located nearthe opening (e.g., any transnasally accessible opening in a paranasalsinus or air cell including but not limited to; natural ostia,surgically altered natural ostia, surgically created openings,antrostomy openings, ostiotomy openings, burr holes, drilled holes,ethmoidectomy openings, natural or man made passageways, etc.) ofinterest. The step of advancement of guide device 900 may be performedunder endoscopic visualization. An initial endoscopic examination mayalso be performed before introducing guide device 900 through the nose.The exact location of the distal end of guide device 900 depends on thesinus to be accessed. To access a maxillary, frontal or anterior Ethmoidsinus, the distal tip of guide device 900 is placed under the middleturbinate just beyond the uncinate process. To access an Ethmoid sinusin patients with an intact middle turbinate, guide device 900 is placedlateral to the middle turbinate. To access a sphenoid or posteriorEthmoid sinus, the distal tip of guide device 900 is passed posteriorly,medial to the middle turbinate. To treat a patient who has alreadyundergone a FESS, sphenoid sinuses may be accessed by advancing guidedevice 900 through what used to be the bulla, lateral to the middleturbinate.

Thereafter, a suitable guidewire 910 is introduced through guide device900 such that the distal end of guidewire 910 emerges out of the distalend of guide device 900. Guidewire 910 is then used to access an openingof a paranasal sinus ((e.g., any transnasally accessible opening in aparanasal sinus or air cell including but not limited to; natural ostia,surgically altered natural ostia, surgically created openings,antrostomy openings, ostiotomy openings, burr holes, drilled holes,ethmoidectomy openings, natural or man made passageways, etc.). Ifguidewire 910 encounters substantial resistance, guidewire 910 isretracted, the position of guidewire 910 is slightly changed and theaccess of the opening of the paranasal sinus is retried. An optionaltorque device may be placed on guidewire 910 during the step ofaccessing the opening of the paranasal sinus if more guidewire torquecontrol and steerability is desired. The position of guide device 900and guidewire 910 can be tracked with fluoroscopy. Successful access ofthe sinus opening of the paranasal sinus is marked by smooth easypassage of guidewire 910 into and beyond the opening of the paranasalsinus. Thereafter, guidewire 910 may be passed into the sinus until somelight resistance is felt or approximately 2-7 cm of the distal portionof guidewire 910 is inside the sinus. The position of guidewire 910 canbe confirmed with fluoroscopy.

Thereafter, a suitable balloon catheter 934 is passed over guidewire 910through guide device 900, into the opening of the paranasal sinus.Thereafter, balloon catheter 934 is positioned across a target region tobe dilated. The position of balloon catheter 934 may be confirmed usingfluoroscopy and/or endoscopy.

Thereafter, an inflation device is used to inflate balloon 938 withgradually increasing pressure. During the step of inflating balloon 938,the diameter, shape and position of the balloon can be tracked usingfluoroscopy and/or endoscopy. Balloon 938 is further inflated untilballoon 938 becomes fully expanded. Care is taken during the step ofinflating balloon 938 to ensure that the pressure in balloon 938 doesnot exceed a maximum allowed pressure. After balloon 938 is fullyexpanded, the pressure created by the inflation device is released. Avacuum is then applied by the inflation device to deflate balloon 938.

Thereafter, guide device 900, guidewire 910 and balloon catheter 934 areremoved together as one unit. The dilation of the opening of theparanasal sinus can be determined using endoscopy.

Several variations of the abovementioned procedure are possible. In onemethod embodiment, guidewire 910 is pre-loaded into guide device 900.Guidewire 910 and guide device 900 are then co-introduced into theanatomy such that the distal tip of guide device 900 is located near atarget region of the anatomy. In another method embodiment, ballooncatheter 934 is preloaded over guidewire 910. The combination of ballooncatheter 934 and guidewire 910 is in turn preloaded inside of guidedevice 900. This combination of balloon catheter 934, guidewire 910 andguide device 900 can be introduced in the nasal cavity such the distalend of the combination is positioned near a desired target region.Thereafter, guidewire 910 is advanced into the desired target regionsuch as a sinus cavity. Thereafter, balloon catheter 934 is advancedover guidewire 910. Balloon 938 is then inflated to dilate an anatomicalregion.

Balloons of different diameters may be used for dilating the same regionof the target anatomy. The target anatomy may be pre-dilated beforedilating the target anatomy by balloon 938. This step is performed byusing a balloon catheter with a balloon of a diameter smaller than thediameter of balloon 938. The target anatomy may be re-dilated afterdilating the target anatomy by balloon 938. This step is performed byusing a balloon catheter with a balloon of a diameter larger than thediameter of balloon 938. The steps of pre-dilation or re-dilation can beperformed by inserting one or more additional balloon catheters over theguidewire used to insert balloon catheter 934. The steps of pre-dilationor re-dilation may be repeated using multiple balloon catheters ifdesired.

Balloon catheter 934 may be used to dilate multiple regions of theanatomy. This method embodiment is especially useful for optimaldilation of a longer passageway. In this technique, the balloon ispositioned in one location, inflated, and then deflated. Instead ofretracting the balloon completely, it is simply repositioned to the newlocation by advancing or retracting it over the guidewire while keepingthe guide and the guidewire in place. The balloon is then re-inflatedand deflated. This process can be repeated multiple times until theentire passageway has been dilated as desired. This may also be employedas a means of predilating the opening of the paranasal sinus to allowsubsequent passage of the balloon catheter. Balloon catheter 934 may beused to break or crack a bony region in an opening of a paranasal sinus((e.g., any transnasally accessible opening in a paranasal sinus or aircell including but not limited to; natural ostia, surgically alterednatural ostia, surgically created openings, antrostomy openings,ostiotomy openings, burr holes, drilled holes, ethmoidectomy openings,natural or man made passageways, etc.) or other anatomical structurewhere bone is substantially covered by mucosal tissue. The breaking orcracking of the bony region may be indicated by a sudden drop in apressure gauge located on the inflation device. The breaking or crackingof the bony region may also be accompanied by an audible sound. Thesudden drop in pressure or the audible sound can be used as feedback ofthe success of the step of breaking or cracking of the bony region.

A sinus seeker such as a maxillary sinus seeker, frontal sinus seekeretc. may be used to locate an opening into a paranasal sinus (e.g., anytransnasally accessible opening in a paranasal sinus or air cellincluding but not limited to; natural ostia, surgically altered naturalostia, surgically created openings, antrostomy openings, ostiotomyopenings, burr holes, drilled holes, ethmoidectomy openings, natural orman made passageways, etc.) and/or to plan a trajectory for introducingone or more devices disclosed herein. The sinus seeker may be usedbefore or after the step of insertion of devices such as guide device900, guidewire 910, sheath device 920, balloon catheter 934, etc.

Endoscope(s) may be used to monitor and/or guide one or more steps ofthe various methods disclosed herein. For example, an endoscope maybeused to direct guidewire 910 into various ostia or ducts or passagewaysto ensure proper placement of guidewire 910. Distal portions of one ormore devices disclosed herein may be of a suitable color to enable theone or more devices to be visualized by the endoscope. A combination ofendoscopic visualization and fluoroscopic visualizations may be used tomonitor and/or guide one or more steps of the various methods disclosedherein.

A sheath device such as sheath device 920 may be used to provide furthersupport and direction during the placement of guidewire 910. In onemethod embodiment, sheath device 920 is introduced through guide device900 such that the distal tip of sheath device 920 is closer to thetarget region than the distal tip of guide device 900. Thereafter,guidewire 910 is introduced through sheath device 920. Thereafter,sheath device 920 is retracted while keeping guidewire 910 in place.Balloon catheter 934 is then inserted over guidewire 934 and the openingof the paranasal sinus is dilated. In one embodiment, after the openingof the paranasal sinus is dilated, balloon 938 is deflated. Thereafter,only balloon catheter 934 is removed from the anatomy while keepingguidewire 910 and guide device 900 in place. Thereafter, sheath device920 is inserted through guide device 900 over guidewire 910 into thesinus. Guidewire 910 is then retracted completely and alternate suctionand irrigation are employed to drain the sinus of any puss, tissue orfluids that may reside within the cavity. In another method embodiment,balloon catheter 934 is used to provide irrigation with or without somelimited suction of low viscosity fluids. This is done after the dilationstep by keeping balloon catheter 934 in the anatomy, removing guidewire910 and then irrigating/suctioning through guidewire lumen of ballooncatheter 934.

FIGS. 10A through 10E′ show side views of embodiments of guide devices.One or more of these guide devices may be provided as a part of thesystem shown in FIGS. 9A through 9D. FIG. 10A shows a side view of afirst embodiment of a guide device comprising a substantially straightdistal portion. Guide device 1000 comprises an elongate tube 1002.Elongate tube 1002 may be made of suitable biocompatible materials suchpolymers e.g. Nylon, Pebax, etc. In a preferred embodiment, the materialof elongate tube 1002 has Rockwell hardness in the range of about 70 Rto about 110 R. In this preferred embodiment, the distal portion isflexible enough to prevent or reduce damage to the anatomy. Yet, thedistal portion is rigid enough to retain its shape as one or moredevices are passed through guide device 900. Furthermore, the distalportion is rigid enough to enable a user to use the distal portion todisplace anatomical structures. The distal portion of elongate tube 1002comprises a curved, bent or angled region curved at an angle of lessthen 5 degrees. In one embodiment, distal portion of elongate tube 1002is substantially straight. The inner surface of elongate tube 1002 maybe lined by a lubricious coating or a tubular lubricious liner made of asuitable biocompatible material such as PTFE. In one embodiment, theouter diameter of elongate tube 1002 is around 0.134+/−0.005 inches. Thedistal portion of elongate tube 1002 comprises an atraumatic tip 1004.Atraumatic tip 1004 may be made of suitable biocompatible materialsincluding, but not limited to Pebax, etc. Atraumatic tip 1004 preventsor reduces damage to the anatomy caused by the distal end of guidedevice 1000. In one embodiment, length of atraumatic tip 1004 is0.08+/−0.04 inches and the material of tip 1004 has Shore Durometerhardness in the range of about 35D to about 72D. Guide device 1000further comprises a hypotube 1006. Hypotube 1006 may be made of suitablebiocompatible materials such as stainless steel 304, titanium, Nitinol,polymers such as Nylon etc. In one embodiment, the outer diameter ofhypotube 1006 is 0.154+/−0.005 inches. In one embodiment of a method ofconstructing guide device 1000, a stainless steel hypotube 1006 isbonded to an elongate tube 1002 such as a Nylon elongate tube 1002 toincrease the strength of elongate tube 1002. In one embodiment, hypotube1006 is heat bonded to elongate tube 1002. One or more openings,perforations or holes may be located on hypotube 1006 to enable materialof elongate tube 1002 to melt into the one or more openings,perforations or holes. When the melted material of elongate tube 1002solidifies, an additional mechanical bonding is created between hypotube1006 and elongate tube 1002. The proximal end of guide device 1000comprises a hub 1008. In one embodiment, hub 1008 is a female luer hub.Hub 1008 may have wings 1009 to enable a user to turn guide device 1000.In one embodiment, the axial length of guide device 1000 is 5+/−0.25inches. In one embodiment, the inner diameter of guide device 1000 isaround 0.1 inches. The distal portion of guide device 1000 may comprisea radiopaque marker. In one embodiment, the radiopaque marker is aplatinum/iridium marker band. The guide device design shown in FIG. 10Ais especially suited for trans-nasal access of the sphenoid sinuses.

FIG. 10B shows a side view of a first embodiment of a guide devicecomprising a bent, angled or curved distal portion. Guide device 1010comprises an elongate tube 1012. Elongate tube 1012 may be made ofsuitable biocompatible materials such polymers e.g. Nylon, Pebax, etc.Elongate tube 1012 comprises a substantially straight proximal portionenclosed by a hypotube and a distal portion comprising a curved, bent orangled region. The angle of the curved, bent or angled region of thedistal portion can range from 5 degrees to 45 degrees. In thisembodiment, distal portion of elongate tube 1012 is bent by an angle ofaround 30 degrees. The inner surface of elongate tube 1012 may be linedby a lubricious coating or a tubular lubricious liner made of a suitablebiocompatible material such as PTFE. In one embodiment, the outerdiameter of elongate tube 1012 is around 0.134+/−0.005 inches. Thedistal portion of elongate tube 1012 comprises an atraumatic tip 1014.Atraumatic tip 1014 may be made of suitable biocompatible materialsincluding, but not limited to Pebax, etc. Atraumatic tip 1014 preventsor reduces damage to the anatomy caused by the distal end of guidedevice 1010. In one embodiment, length of atraumatic tip 1014 is0.08+/−0.04 inches. Guide device 1010 further comprises a hypotube 1016covering the proximal portion of elongate tube 1012. Hypotube 1016 maybe made of suitable biocompatible materials such as stainless steel 304,titanium, Nitinol, polymers such as Nylon etc. In one embodiment, theouter diameter of hypotube 1016 is 0.154+/−0.005 inches. In oneembodiment of a method of constructing guide device 1010, a stainlesssteel hypotube 1016 is bonded to a Nylon elongate tube 1012. Theproximal end of guide device 1010 comprises a hub 1018. In oneembodiment, hub 1018 is a female luer hub. Hub 1018 may have wings 1019to enable a user to turn guide device 1010. Wings 1019 may be aligned inthe plane of the curve of the distal tip as an indicator of the positionand orientation of the distal tip in the anatomy. In one embodiment, theaxial length of guide device 1010 is 5+/−0.25 inches. In one embodiment,the inner diameter of guide device 1010 is around 0.1 inches. The distalportion of guide device 1010 may comprise a radiopaque marker. In oneembodiment, the radiopaque marker is a platinum/iridium marker band.FIG. 10B′ shows an enlarged view of the distal portion of the guidedevice in FIG. 10B. FIG. 10B′ shows elongated tube 1012 enclosed byhypotube 1016. Distal end of elongated tube 1012 comprises atraumatictip 1014. Several parameters defined hereafter characterize the designof the distal portion of guide device 1010. The width of the distal endof guide device 1010 is called W as shown. The length measured from theproximal-most point on the distal curved portion of elongate tube 1012to the distal tip is called L1. L1 is measured along the lineardirection of the straight proximal portion of guide device 1010 as shownin FIG. 10B′. The length of the straight region of elongate tube 1012from the distal end of the proximal portion till the proximal most pointon the curved region of the distal portion is called L2. In oneparticular embodiment, W is 0.34+/−0.08 inches, L1 is 0.46+/−0.08inches, L2 is 0 to 2 inches and the radius of curvature of the distalcurved region of elongate tube 1012 is 0.180 inches. The guide devicedesign shown in FIGS. 10B and 10B′ is especially suited for trans-nasalaccess of the sphenoid sinuses.

FIG. 10C shows a side view of a second embodiment of a guide devicecomprising a bent, angled or curved distal portion. The design of guidedevice 1020 is similar to the design of guide device 1010. Guide device1020 comprises an elongate tube 1022. The distal portion of elongatetube 1022 comprises a curved, bent or angled region curved at an angleranging from 30 degrees to 100 degrees. In this embodiment, distalportion of elongate tube 1022 is bent by an angle of around 70 degrees.The distal portion of elongate tube 1022 comprises an atraumatic tip1024. Guide device 1020 further comprises a hypotube 1026. The proximalend of guide device 1020 comprises a hub 1028. In one embodiment, hub1028 is a female luer hub. Hub 1028 may have wings 1029 to enable a userto turn guide device 1020. FIG. 10C′ shows an enlarged view of thedistal portion of the guide device in FIG. 10C. FIG. 10C′ showselongated tube 1022 enclosed by hypotube 1026. Distal end of elongatedtube 1022 comprises atraumatic tip 1024. In one particular embodiment, Wis 0.45+/−0.08 inches, L1 is 0.32+/−0.08 inches, L2 is 0 to 2 inches andthe radius of curvature of the distal curved region of elongate tube1022 is 0.180 inches. The guide device design shown in FIGS. 10C and10C′ is especially suited for trans-nasal access of the frontal sinuses.

FIG. 10D shows a side view of a second embodiment of a guide devicecomprising a bent, angled or curved distal portion. The design of guidedevice 1030 is similar to the design of guide device 1010. Guide device1030 comprises an elongate tube 1032. The distal portion of elongatetube 1032 comprises a curved, bent or angled region curved at an angleranging from 70 degrees to 135 degrees. In this embodiment, distalportion of elongate tube 1032 is bent by an angle of around 90 degrees.The distal portion of elongate tube 1032 comprises an atraumatic tip1034. Guide device 1030 further comprises a hypotube 1036. The proximalend of guide device 1030 comprises a hub 1038. In one embodiment, hub1038 is a female luer hub. Hub 1038 may have wings 1039 to enable a userto turn guide device 1030. FIG. 10D′ shows an enlarged view of thedistal portion of the guide device in FIG. 10D. FIG. 10D′ showselongated tube 1032 enclosed by hypotube 1036. Distal end of elongatedtube 1032 comprises atraumatic tip 1034. In one particular embodiment, Wis 0.39+/−0.080 inches, L1 is 0.25+/−0.08 inches, L2 is 0 to 2 inchesand the radius of curvature of the distal curved region of elongate tube1032 is 0.180 inches. W may be as small as 5 mm with a correspondingreduction in the radius of curvature of the distal curved region ofelongate tube 1032. The guide device design shown in FIGS. 10D and 10D′is especially suited for trans-nasal access of the maxillary sinuses.

FIG. 10E shows a side view of a second embodiment of a guide devicecomprising a bent, angled or curved distal portion. The design of guidedevice 1040 is similar to the design of guide device 1010. Guide device1040 comprises an elongate tube 1042. The distal portion of elongatetube 1042 comprises a curved, bent or angled region curved at an angleranging from 100 degrees to 120 degrees. In this embodiment, distalportion of elongate tube 1042 is bent by an angle of around 110 degrees.The distal portion of elongate tube 1042 comprises an atraumatic tip1044. Guide device 1040 further comprises a hypotube 1046. The proximalend of guide device 1040 comprises a hub 1048. In one embodiment, hub1048 is a female luer hub. Hub 1048 may have wings 1049 to enable a userto turn guide device 1040. FIG. 10E′ shows an enlarged view of thedistal portion of the guide device in FIG. 10E. FIG. 10E′ showselongated tube 1042 enclosed by hypotube 1046. Distal end of elongatedtube 1042 comprises atraumatic tip 1044. In one particular embodiment, Wis 0.46+/−0.08 inches, L1 is 0.25+/−0.08 inches, L2 is 0 to 0.5 inchesand the radius of curvature of the distal curved region of elongate tube1042 is 0.180 inches. L1 and W may be smaller than 0.25+/−0.08 inchesand 0.46+/−0.08 inches respectively. The guide device design shown inFIGS. 10E and 10E′ is especially suited for trans-nasal access of themaxillary sinuses.

FIG. 10F shows a partial longitudinal sectional view through the plane10-10 in FIG. 10A showing a first embodiment of the distal tip of aguide device. Distal portion of guide device 1000 comprises elongatetube 1002. Distal portion of elongate tube 1002 has an atraumatic tip1004. In this embodiment, the distal edge of atraumatic tip 1004 has atapered distal edge to reduce tissue injury due to guide device 1000.Guide device 1000 further comprises a radiographic marker band 1050. Inthis embodiment, marker band 1050 is located on the inner surface ofatraumatic tip 1004. Guide device 1000 further comprises a lubriciousliner 1052 located on the inner surface of guide device 1000.

FIG. 10G shows a partial longitudinal sectional view through the plane10-10 in FIG. 10A showing a second embodiment of the distal tip of aguide device. Distal portion of guide device 1000 comprises elongatetube 1002. Distal portion of elongate tube 1002 has an atraumatic tip1004. In this embodiment, the distal edge of atraumatic tip 1004 has arounded distal edge to reduce tissue injury due to guide device 1000.Guide device 1000 further comprises a radiographic marker band 1050. Inthis embodiment, marker band 1050 is located on the inner surface ofatraumatic tip 1004. Guide device 1000 further comprises a lubriciousliner 1052 located on the inner surface of guide device 1000.

FIG. 11 shows a perspective view of an embodiment of a guide device.Guide device 1100 comprises an elongate tube 1102. The distal portion ofelongate tube 1102 comprises a curved, bent or angled region. The distalportion of elongate tube 1102 comprises an atraumatic tip 1104. Guidedevice 1100 further comprises a hypotube 1106. The proximal end of guidedevice 1100 comprises a hub 1108. In one embodiment, hub 1108 is afemale luer hub. Hub 1108 may have wings 1110 to enable a user to torqueguide device 1100. FIG. 11A shows a cross sectional view through line11A-11A of FIG. 11. FIG. 11A shows a cross section of guide device 1100showing elongate tube 1102 surrounded by hypotube 1106. In thisembodiment, inner surface of elongate tube 1106 is lined by a lubriciouscoating or a lubricious liner 1112. Lubricious liner 1112 may be made ofsuitable biocompatible materials such as PTFE. FIG. 11B shows a crosssectional view through line 11B-11B of FIG. 11. FIG. 11B shows a crosssection of guide device 1100 showing elongate tube 1102. In thisembodiment, inner surface of elongate tube 1106 is lined by a lubriciouscoating or a lubricious liner 1112. FIG. 11C shows a cross sectionalview through line 11C-11C of FIG. 11. FIG. 11C shows a cross section ofguide device 1100 showing atraumatic tube 1104 enclosing a radiographicmarker band 1114. In this embodiment, inner surface of guide device 1100is lined by a lubricious coating or a lubricious liner 1112. FIG. 11C′shows an enlarged view of region 11C′ in FIG. 11C showing atraumatictube 1104 enclosing radiographic marker band 1114 and lubricious liner1112.

FIG. 12 shows a longitudinal sectional view of a guidewire. Guidewire1200 is a flexible guidewire comprising a core wire comprising aproximal portion 1202, a middle portion 1204 and a distal portion 1206.In one embodiment, proximal portion 1202 and distal portion 1206 aresubstantially cylindrical with the diameter of proximal portion 1202greater than the diameter of distal portion 1206. This causes the distalportion of guidewire 1200 to be substantially floppy. In one embodiment,the length of the floppy region is about 20 cm. Middle portion comprisesa tapered shape. The core wire can be made of suitable biocompatiblematerials such as stainless steel, Nitinol, etc. Guidewire 1200 furthercomprises an outer coil 1208. Outer coil 1208 may be made of suitablebiocompatible materials including, but not limited to stainless steel.Outer coil 1208 is connected to the core wire at the distal end ofguidewire 1200 by a smooth, burr free soldered or welded distal joint1210 to get an atraumatic distal tip. Similarly, outer coil 1208 isconnected to the core wire at the proximal end of guidewire 1200 by asmooth, burr free soldered or welded proximal joint 1212 to get anatraumatic proximal tip. Guidewire 1200 may further comprise an innercoil located on the distal portion of guidewire 1200 enclosed by outercoil 1208. The inner coil may be made of suitable radiopaque materialsto allow visualization of the distal portion of guidewire 1200 underfluoroscopy. In one particular embodiment, the inner coil is made of analloy of 92% platinum and 8% tungsten. A part or the entire outersurface of guidewire 1200 may comprise a lubricious coating such as aPTFE coating. In one embodiment, the length A of middle portion 1204 isabout 16.5 cm, length B of distal portion 1206 is about 7 cm and thetotal length C of guidewire 1200 is about 75 cm. In another embodiment,the length A of middle portion 1204 is about 17 cm, length B of distalportion 1206 is about 7 cm and the total length C of guidewire 1200 isabout 120 cm. In another embodiment, the length A of middle portion 1204is about 13 cm, length B of distal portion 1206 is about 11 cm and thetotal length C of guidewire 1200 is about 120 cm. In one embodiment, thediameter of guidewire 1200 is about 0.035 inches. Various designs ofguidewire 1200 may be used to design guidewire 910 in FIG. 9B. Multipleguidewires with various design parameters such as outer diameter,stiffness, length may be supplied as a part of a system such as thesystem shown in FIGS. 9A through 9D. Guidewire 1200 may be used toaccess various regions in the anatomy. It can be used to facilitateplacement of other devices during various diagnostic or therapeuticprocedures. Guidewire 1200 may be torquable to facilitate navigation ofguidewire 1200 especially through tortuous anatomy. Specific uses ofguidewire 1200 include, but are not limited to introduction and supportof various diagnostic or therapeutic devices for performing proceduressuch as sinus ostia dilation, lavage of anatomical spaces such asparanasal sinuses, suction, etc. Another specific use of guidewire 1200is introduction of devices for treatment of the middle ear via theEustachian tube. A portion of the distal end of guidewire 1200 may beintroduced into a paranasal sinus so that the portion of guidewire 1200is coiled inside the paranasal sinus. This enables a user to estimatethe contour of the paranasal sinus.

FIG. 13A shows an embodiment of a sheath device comprising asubstantially straight distal end. Sheath device 1350 comprises aflexible elongate shaft 1352. Elongate shaft 1352 is substantiallystraight and comprises a lumen. Elongate shaft 1352 may be made ofsuitable biocompatible materials including, but not limited topolyethylene, Nylon, etc. In one embodiment, elongate shaft 1352comprises a stiffening means including, but not limited to metal braidsor coils, polymer jackets, etc. In another embodiment, stiffness ofelongate shaft 1352 is increased by crosslinking material of elongateshaft 1352 by exposing it to an electron beam. Distal end of elongateshaft 1352 may comprise an atraumatic tip made of a soft polymer or aradiused tip. Distal portion of elongate shaft 1352 may also comprise aradiopaque marker such as a platinum-iridium radiographic marker toenable visualization of the distal portion of elongate shaft 1352 underfluoroscopy. The inner surface of elongate shaft may be lined with alubricious coating or a lubricious inner liner. The proximal end ofelongate shaft 1352 comprises a hub 1354. In one embodiment, hub 1354 isa female luer hub. Hub 1354 comprises one or more wings 1356 that areused by a user to torque sheath device 1350. A strain relief tubing 1358may be provided between hub 1354 and elongate shaft 1352. Strain relieftubing 1358 may be made of suitable biocompatible materials such aspolyimide. Sheath device 1350 may be made in various sizes and shapes tofacilitate access to various anatomical regions such as variousparanasal sinuses and passageways and openings leading to the paranasalsinuses. In an embodiment, the effective length of sheath device 1350 is29+/−1 cm, the outer diameter of elongate shaft 1352 is 0.052+/−0.003inches, and inner diameter of elongate shaft 1352 is 0.040+/−0.003inches. Such a device is compatible with guide devices of an innerdiameter greater than 0.056 inches. Such a device is especially suitedfor lavaging an anatomical region. In another embodiment, the effectivelength of sheath device 1350 is 35+/−2 cm, the outer diameter ofelongate shaft 1352 is 0.059+/−0.002 inches, and inner diameter ofelongate shaft 1352 is 0.039+/−0.001 inches Such a device is compatiblewith guide devices of an inner diameter greater than 0.065 inches. Sucha device is especially suited for suctioning an anatomical region,exchanging elongate devices, supporting the introduction or removal ofelongate devices, etc. In another embodiment, the effective length ofsheath device 1350 is 22+/−1 cm, the outer diameter of elongate shaft1352 is 0.088+/−0.002 inches, and inner diameter of elongate shaft 1352is 0.065+/−0.001 inches. Such a device is compatible with guide devicesof an inner diameter greater than 0.097 inches. Such a device isespecially suited for suctioning an anatomical region, supporting theintroduction of thinner elongate devices, etc.

FIG. 13B shows another embodiment of a sheath device comprising a bent,curved or angled distal end. Design of sheath device 1360 issubstantially similar to design of sheath device 1350. Sheath device1360 comprises a flexible elongate shaft 1362. The distal portion ofelongate shaft 1362 comprises a bent, curved or angled region tofacilitate access to various anatomical regions such as variousparanasal sinuses and passageways and openings leading to the paranasalsinuses. In one embodiment, distal portion of elongate shaft 1362comprises a bent region bent by an angle of around 30 degrees. Inanother embodiment, distal portion of elongate shaft 1362 comprises abent region bent by an angle of around 45 degrees. The proximal end ofelongate shaft 1362 comprises a hub 1364. In one embodiment, hub 1364 isa female luer hub. Hub 1364 comprises one or more wings 1366 that areused by a user to torque sheath device 1360. Wings 1366 may be alignedin the plane of the bent, curved or angled region of the elongate shaft1362. A strain relief tubing 1368 may be provided between hub 1364 andelongate shaft 1362. In an embodiment, the effective length of sheathdevice 1360 is 29+/−1 cm, the outer diameter of elongate shaft 1362 is0.052+/−0.003 inches, and inner diameter of elongate shaft 1362 is0.040+/−0.003 inches. Such a device is compatible with guide devices ofan inner diameter greater than 0.056 inches. Such a device is especiallysuited for ravaging an anatomical region. In another embodiment, theeffective length of sheath device 1360 is 35+/−2 cm, the outer diameterof elongate shaft 1362 is 0.059+/−0.002 inches, and inner diameter ofelongate shaft 1362 is 0.039+/−0.001 inches Such a device is compatiblewith guide devices of an inner diameter greater than 0.065 inches. Sucha device is especially suited for suctioning an anatomical region,exchanging elongate devices, supporting the introduction or removal ofelongate devices, etc. In another embodiment, the effective length ofsheath device 1360 is 22+/−1 cm, the outer diameter of elongate shaft1362 is 0.088+/−0.002 inches, and inner diameter of elongate shaft 1362is 0.065+/−0.001 inches. Such a device is compatible with guide devicesof an inner diameter greater than 0.097 inches. Such a device isespecially suited for suctioning an anatomical region, supporting theintroduction of thinner elongate devices, etc.

Sheath device 1350 and sheath device 1360 can be used as a part of thesystem shown in FIGS. 9A through 9D. The sheath devices disclosed hereincan be used for lavage, suction, and exchange of wires in anatomicalregions such as the paranasal sinuses. The sheath devices may also beused to redirect guide wires during guide wire probing. Specific usesfor the sheath devices include, but are not limited to, the introductionand support of various interventional and diagnostic devices whenperforming procedures such as sinus ostia dilation, sinus lavage, andsuction. The sheath devices may also be used for other applicationsincluding, but not limited to treatment of the middle ear via theEustachian tube, etc.

FIG. 14 shows a side view of en embodiment of a balloon catheter. Theballoon catheter design disclosed in FIG. 14 may be used as ballooncatheter 934 in FIG. 9D. In FIG. 14, balloon catheter 1400 comprises anelongate shaft 1402. In one embodiment, outer diameter of elongate shaft1402 is around 0.046″+/−0.005″. In another embodiment, outer diameter ofelongate shaft 1402 is around 0.066″+/−0.005″. Elongate shaft 1402comprises a guidewire lumen to allow balloon catheter 1400 to beintroduced over a guidewire such as a 0.035″ guidewire. A balloon 1404is located on the distal portion of elongate shaft 1402. In oneembodiment, balloon 1404 is a non-compliant balloon of complianceranging from 0.025 to 0.030 mm per atmosphere. Balloon 1404 may be madeof suitable biocompatible materials including, but not limited to PET,Nylon, etc. Balloon 1404 may be coated with one or more balloon coatingsincluding, but not limited to puncture resistance coating, abrasionresistance coating, anti-tack coating, etc. In a particular embodiment,balloon 1404 is made of PET of a wall thickness around 0.002 inchescoated by a 0.002 inch thick polyurethane coating with a tensilestrength of 12,000 to 16,000 psi and a burst pressure of more than 16atmospheres. The working length of balloon 1404 may range from 4 mm to50 mm. In one embodiment, working length of balloon is around 16+/−1 mm.Balloon 1404 may be inflated to a suitable working pressure of around 12to 16 atmospheres. In one embodiment of a system comprising multipleballoon catheters, three balloon catheters of inflated balloon diametersaround 3+/−0.5 mm, 5+/−0.5 mm and 7+/−0.5 mm are provided in the system.In another embodiment of a system comprising multiple balloon catheters,two balloon catheters of inflated balloon diameters around 5+/−0.5 mmand 7+/−0.5 mm are provided in the system. Balloon catheter 1400 of aninflated balloon diameter around 7 mm is especially suitable fordilating passageways leading to the maxillary sinuses. Balloon catheter1400 of an inflated balloon diameter around 9 mm is especially suitablefor dilating passageways leading to the paranasal sinuses in patientsthat have undergone a previous sinus surgery. Balloon 1404 may be foldedto reduce its profile. The folding may be done to produce multiplefolded wings of the balloon material. For example, a 7 mm diameterballoon may be folded to produce 4 to 7 folded wings of the balloonmaterial. In the embodiment of balloon catheter 1400 shown in FIG. 14,the proximal end of balloon catheter 1400 comprises a ‘Y’ connector1406. The proximal end of ‘Y’ connector 1406 comprises a first luer port1408 that leads to a guidewire lumen in balloon catheter 1400. ‘Y’connector 1406 further comprises a second luer port 1410 that is influid communication with a balloon inflation lumen in balloon catheter1400. Balloon 1404 is inflated by injecting a suitable inflation mediumsuch as diluted contrast solution through second luer port 1410 by aninflation device 1412. In one embodiment, inflation device 1412 isconnected to second luer port 1410 by a segment of extension tubing. Astress relief tubing 1414 may be located between ‘Y’ connector 1406 andelongate shaft 1402. Elongate shaft 1402 may comprise a first cathetershaft marker 1416 with or without a second catheter shaft marker 1418.In one embodiment, length of balloon catheter 1400 is 30+/−1 cm.

FIGS. 14A and 14B show cross sectional views of the balloon catheter ofFIG. 14 through lines 14A-13A and 14B-13B respectively. FIG. 14A shows across section of elongate shaft 1402. Elongate shaft 1402 comprises anouter tube 1420 and an inner tube 1422. Outer tube 1420 and inner tube1422 can be made of suitable biocompatible polymers including, but notlimited to Pebax, Nylon, etc. Inner tube 1422 encloses a guidewirelumen. In one embodiment, the guidewire lumen has an internal diametergreater than 0.0155 inches to enable insertion of balloon catheter 1400into the anatomy over a 0.014″ guidewire. In another embodiment, theguidewire lumen has an internal diameter greater than 0.0360 inches toenable insertion of balloon catheter 1400 into the anatomy over a 0.035″guidewire. The lumen between outer tube 1420 and an inner tube 1422encloses a balloon inflation lumen that is in fluid communication withballoon 1404. FIG. 14B shows a cross section of elongate shaft 1402 at aregion distal to balloon 1404. Elongate shaft 1402 comprises an innertube 1422 without outer tube 1420 since outer tube 1420 opens intoballoon 1404. FIG. 14C shows an enlarged view of segment 14C of FIG. 14.Distal end of outer tube 1420 opens into balloon 1404. In oneembodiment, the length of inner tube 1422 distal to balloon 1404 is3.0+/−0.75 mm. In another embodiment, the length of inner tube 1422distal to balloon 1404 is 5.0+/−0.75 mm. In this example, balloon 1404is a standard balloon comprising a cylindrical body, two conical tapers,and two necks. Alternatively, balloon 1404 may also comprise other typesof balloon designs. The portion of inner tube 1422 enclosed by balloon1404 may comprise one or more radiographic markers. In this example,inner tube 1422 comprises two radiographic markers 1424. Radiographicmarkers 1424 are used to verify the position of balloon 1404 during theuse of balloon catheter 1400. FIG. 14D shows an enlarged perspectiveview of segment 14D in FIG. 14. Elongate shaft 1402 comprises visualmarkers such as a first catheter shaft marker 1416 and a second cathetershaft marker 1418. The visual markers are used to verify relativelocation of balloon 1404 relative to distal end of a guide device whenballoon catheter 1404 is introduced through the guide device. Whensecond balloon catheter shaft marker 1481 enters the proximal end of theguide device, the distal tip of balloon catheter 1400 emerges out of thedistal end of the guide device. First catheter shaft marker 1416 startsto enter the proximal end of the guide device when the material ofballoon 1404 starts to emerge out of the distal end of the guide device.First catheter shaft marker 1416 completely enters proximal end of theguide device when material of balloon 938 completely emerges out of thedistal end of the guide device. Thus, erroneous inflation of balloon1404 within the guide device can be prevented. In one embodiment, thedistance from the distal end of first catheter shaft marker 1316 and thedistal tip of balloon catheter 1400 is 15.0+/−1.0 cm. FIG. 14E shows across sectional view of the balloon in FIG. 14C through line 14E-14E.Inner tube 1422 is surrounded by balloon 1404. Balloon 1404 is made ofsuitable biocompatible materials and may comprise one or more coatingson the outer surface of balloon 1404.

A probing tool could be used in conjunction with the various methods anddevices disclosed herein. The probing tool is a generally rigid,elongate element that is inserted through the nose. The distal end ofthe probing tool may be substantially straight or may comprise a curved,angled or bent region. The distal region or end of the probing tool isadvanced to reach an opening of a paranasal sinus (e.g., anytransnasally accessible opening in a paranasal sinus or cranio-facialair cell, including but not limited to; natural ostia, surgically ormedically altered ostia, surgically created or man made openings,antrostomy openings, ostiotomy openings, trephination openings, burrholes, drilled holes, ethmoidectomy or an anatomical regionsubstantially near such opening of a paranasal sinus. The probing toolis then used to determine the location and/or that opening or anatomicalregion. Information about the location and/or the orientation of thatopening or anatomical region can be appreciated or determined in manyways.

For example, the orientation of the proximal region of the probing tooloutside the nose provides the user information about the location and/orthe orientation of the opening or anatomical region. In a secondembodiment, the location and/or orientation of the probing tool in theanatomy is visualized under endoscopic and/or fluoroscopic visualizationto provide the user information about the location and/or theorientation of the opening or anatomical region. In a third embodiment,the probing tool comprises a navigational modality such as anelectromagnetic surgical navigation modality. The location andorientation of the distal region of the probing tool can then bevisualized using the electromagnetic surgical navigation modality toobtain information about the location and/or the orientation of theopening or anatomical region. The information about the location and/orthe orientation of an opening or anatomical region is then used to planthe trajectory of introducing one or more diagnostic, therapeutic orintroducing devices into the opening or anatomical region. This has theadvantage of reducing procedure time. Examples of such probing toolsinclude, but are not limited to frontal sinus seekers, maxillary sinusseekers, etc. The probing tools may be solid or may comprise a lumen.The diagnostic, therapeutic or introducing devices may be introducedover the probing devices, through the probing device or may replace theprobing device. The probing tools may be made of suitable biocompatiblematerials including, but not limited to stainless steel, Nitinol,polymers etc.

As described herein, the present invention includes methods foraccessing an opening of a paranasal sinus (e.g., any transnasallyaccessible opening in a paranasal sinus or cranio-facial air cell,including but not limited to; natural ostia, surgically or medicallyaltered ostia, surgically created or man made openings, antrostomyopenings, ostiotomy openings, trephination openings, burr holes, drilledholes, ethmoidectomy openings, anatomical passageways, natural or manmade passages, etc.) or other anatomical region substantially near suchopening of a paranasal sinus. In these methods a probing tool, such as amaxillary sinus seeker, is used to determine the location andorientation of the opening or anatomical region (e.g., the maxillarysinus ostium). In the case of a maxillary sinus ostium, this is done bynavigating the distal region of the maxillary sinus seeker around theuncinate process such that the distal end of the maxillary sinus seekerenters the maxillary sinus ostium. The position and orientation of theproximal region of the maxillary sinus seeker is then used to determinethe location and/or orientation of the maxillary sinus ostium.Thereafter, the maxillary sinus seeker is removed from the anatomy.Thereafter, a diagnostic or therapeutic device e.g. a fixed wire ballooncatheter is used to access the maxillary sinus ostium. Alternatively, anaccess device e.g. a guide device may be placed in a suitable locationand orientation and a diagnostic or therapeutic device may be advancedinto the maxillary sinus ostium using the guide device.

In another embodiment of a method of accessing an ostium or a passagewayleading to a paranasal sinus, a probing tool such as a frontal sinusseeker comprising a lumen is used to determine the location andorientation of the passageway leading to a frontal sinus. Thereafter, aguidewire is introduced through the lumen of the frontal sinus seekerinto the frontal sinus. Thereafter, the frontal sinus seeker isexchanged over the guidewire for a diagnostic or therapeutic device suchas a balloon catheter.

The term “diagnostic or therapeutic substance” as used herein is to bebroadly construed to include any feasible drugs, prodrugs, proteins,gene therapy preparations, cells, diagnostic agents, contrast or imagingagents, biologicals, etc. Such substances may be in bound or free form,liquid or solid, colloid or other suspension, solution or may be in theform of a gas or other fluid or nan-fluid. For example, in someapplications where it is desired to treat or prevent a microbialinfection, the substance delivered may comprise pharmaceuticallyacceptable salt or dosage form of an antimicrobial agent (e.g.,antibiotic, antiviral, antiparasitic, antifungal, etc.), acorticosteroid or other anti-inflammatory (e.g., an NSAID), adecongestant (e.g., vasoconstrictor), a mucous thinning agent (e.g., anexpectorant or mucolytic), an agent that prevents of modifies anallergic response (e.g., an antihistamine, cytokine inhibitor,leucotriene inhibitor, IgE inhibitor, immunomodulator), etc. Othernon-limiting examples of diagnostic or therapeutic substances that maybe useable in this invention are described in copending U.S. patentapplication Ser. No. 10/912,578 entitled Implantable Devices and Methodsfor Delivering Drugs and Other Substances to Treat Sinusitis and OtherDisorders filed on Aug. 4, 2004, the entire disclosure of which isexpressly incorporated herein by reference.

The term “nasal cavity” used herein to be broadly construed to includeany cavity that is present in the anatomical structures of the nasalregion including the nostrils and paranasal sinuses.

The term “trans-nasal” means through a nostril.

Reference herein to an “opening of a paranasal sinus” pr “opening in aparanasal sinus” shall mean: any transnasally accessible opening in aparanasal sinus or cranio-facial air cell, including but not limited to;natural ostia, surgically or medically altered ostia, surgically createdor man made openings, antrostomy openings, ostiotomy openings,trephination openings, burr holes, drilled holes, ethmoidectomyopenings, anatomical passageways, natural or man made passages, etc.

Although the methods and devices disclosed herein are illustrated inconjunction with particular paranasal sinuses, it is understood thatthese methods and devices can be used in other paranasal sinuses as wellas other anatomical passageways of the ear, nose or throat.

Optionally, any of the working devices and guide catheters describedherein may be configured or equipped to receive or be advanced over aguidewire or other guide member (e.g., an elongate probe, strand ofsuure material, other elongate member) unless to do so would render thedevice inoperable for its intended purpose. Some of the specificexamples described herein include guidewires, but it is to beappreciated that the use of guidewires and the incorporation ofguidewire lumens is not limited to only the specific examples in whichguidewires or guidewire lumens are shown. The guidewires used in thisinvention may be constructed and coated as is common in the art ofcardiology. This may include the use of coils, tapered or non-taperedcore wires, radioopaque tips and/or entire lengths, shaping ribbons,variations of stiffness, PTFE, silicone, hydrophilic coatings, polymercoatings, etc. For the scope of this invention, these wires may possessdimensions of length between 5 and 75 cm and outer diameter between0.005″ and 0.050″.

Several modalities can be used with the devices and methods disclosedherein for navigation and imaging of the devices within the anatomy. Forexample, the devices disclosed herein may comprise an endoscope forvisualization of the target anatomy. The devices may also compriseultrasound imaging modalities to image the anatomical passageways andother anatomical structures. The devices disclosed herein may compriseone or more magnetic elements especially on the distal end of thedevices. Such magnetic elements may be used to navigate through theanatomy by using external magnetic fields. Such navigation may becontrolled digitally using a computer interface. The devices disclosedherein may also comprise one or more markers (e.g. infra-red markers).The markers can be used to track the precise position and orientation ofthe devices using image guidance techniques. Several other imaging ornavigating modalities including but not limited to fluoroscopic,radiofrequency localization, electromagnetic, magnetic and otherradiative energy based modalities may also be used with the methods anddevices disclosed herein. These imaging and navigation technologies mayalso be referenced by computer directly or indirectly to pre-existing orsimultaneously created 3-D or 2-D data sets which help the doctor placethe devices within the appropriate region of the anatomy.

The distal tip of devices mentioned herein may comprise a flexible tipor a soft, atraumatic tip. Also, the shaft of such devices may bedesigned for enhanced torquability.

The embodiments herein have been described primarily in conjunction withminimally invasive procedures, but they can also be used advantageouslywith existing open surgery or laparoscopic surgery techniques.

It is to be appreciated that the invention has been described hereabovewith reference to certain examples or embodiments of the invention butthat various additions, deletions, alterations and modifications may bemade to those examples and embodiments without departing from theintended spirit and scope of the invention. For example, any element orattribute of one embodiment or example may be incorporated into or usedwith another embodiment or example, unless to do so would render theembodiment or example unsuitable for its intended use. Also, where thesteps of a method or process are described, listed or claimed in aparticular order, such steps may be performed in any other order unlessto do so would render the embodiment or example un-novel, obvious to aperson of ordinary skill in the relevant art or unsuitable for itsintended use. All reasonable additions, deletions, modifications andalterations are to be considered equivalents of the described examplesand embodiments and are to be included within the scope of the followingclaims.

The invention claimed is:
 1. A method for using a balloon that has anon-expanded configuration and an expanded configuration to dilate anatural paranasal sinus ostium that has not previously been surgicallyaltered, the natural paranasal sinus ostium being formed by mucosa withunfractured bone underlying the mucosa, said method comprising the stepsof: (A) advancing an elongate guide having a distal end and a lumen to aposition within or near the natural paranasal sinus ostium (B) insertinga balloon catheter through the lumen of the elongate guide to position aballoon of the balloon catheter beyond the distal end of the guide andwithin the natural paranasal sinus ostium; (C) expanding the balloonwithin the natural paranasal sinus ostium sufficiently to break,remodel, or rearrange the bone underlying the mucosa of the ostiumthereby enlarging the natural paranasal sinus ostium to an enlargedostium; and (D) deflating the balloon, removing the balloon catheterfrom the enlarged ostium, and removing the elongate guide from near theostium.
 2. A method according to claim 1 wherein the guide has a curveand wherein the advancing step comprises advancing the balloon throughthe lumen of the guide and around the curve.
 3. A method according toclaim 1 wherein at least a portion of the guide is malleable and whereinthe method further comprises the step of: shaping a malleable portion ofthe guide.
 4. A method according to claim 3 wherein the guide comprisesa flexible guide catheter and a malleable outer tube through which theballoon catheter extends.
 5. A method according to claim 1 wherein theinserting step comprises: inserting the elongate guide to a firstposition; and advancing a guidewire through the lumen of the elongateguide such that the guidewire extends into or through the naturalparanasal sinus ostium, wherein the advancing step further comprisesadvancing the balloon catheter over the guidewire to a position wherethe balloon is positioned within the natural paranasal sinus ostium. 6.A method according to claim 1 wherein a distal end of the ballooncatheter is bent or angled.
 7. A method according to claim 1 furthercomprising using an endoscope for visualization.
 8. A method accordingto claim 1 further comprising advancing the balloon through a lumen of astabilizing member.
 9. A method according to claim 1 wherein the naturalparanasal sinus ostium is a maxillary sinus ostium.
 10. A methodaccording to claim 1 wherein the natural paranasal sinus ostium is afrontal sinus ostium.
 11. A method according to claim 1 furthercomprising treating an ethmoid sinus.
 12. A method according to claim 1wherein the balloon catheter has at least one distance marking or markerband.
 13. A method according to claim 1, wherein the balloon comprises acylindrical balloon having a first end and a second end with acylindrical surface therebetween, and wherein the inflation of theballoon within the natural paranasal sinus ostium radially expands thecylindrical surface against the surrounding ostium.
 14. A methodaccording to claim 13, wherein a diameter of the inflated cylindricalballoon is sufficiently greater than a diameter of the natural paranasalsinus ostium.
 15. A method according to claim 1, wherein the enlargingof the ostium, the deflating of the balloon, and the removing of theballoon catheter are included in a procedure performed while the patientis disposed in a clinical working environment.
 16. A method of claim 1,wherein the method is performed on a patient suffering from sinusitisand wherein enlarging of the ostium is performed so that, after thedeflating of the balloon and removing of the balloon catheter and theelongate guide, outflow from the paranasal sinus is enhanced such thatthe sinusitis of the patient is mitigated.
 17. A method of claim 1,wherein the enlarging of the ostium is performed so that, after thedeflating of the balloon and removing of the balloon catheter and theelongate guide, drainage of mucus from the paranasal sinus is enhancedsuch that the sinusitis of the patient is mitigated.
 18. A method fortreating sinusitis of a patient having a paranasal sinus with anassociated ostium, the ostium being a natural paranasal sinus ostiumthat has not previously been surgically altered, the natural paranasalsinus ostium formed by mucosa with unfractured bone underlying themucosa, the method comprising the steps of: advancing an elongate guidehaving a distal end and a lumen to a position within or near the naturalparanasal sinus ostium; advancing a balloon of a balloon catheterthrough the lumen of the elongate guide to position the balloon beyondthe distal end of the guide and within the natural paranasal sinusostium; enlarging the natural paranasal sinus ostium to an enlargedostium by inflating the balloon within the natural paranasal sinusostium sufficiently to break, remodel, or rearrange the bone underlyingthe mucosa of the ostium; and deflating the balloon, removing theballoon catheter from the enlarged ostium, and removing the elongateguide from near the ostium.
 19. A method according to claim 18 whereinthe guide has a curve and wherein the advancing step comprises advancingthe balloon through the lumen of the guide and around the curve.
 20. Amethod according to claim 19 wherein at least a portion of the guide ismalleable and wherein the method further comprises the step of: shapinga malleable portion of the guide.
 21. A method according to claim 20wherein the guide comprises a flexible guide catheter and a malleableouter tube through which the balloon catheter extends.
 22. A methodaccording to claim 18 wherein the inserting step comprises: insertingthe elongate guide to a first position; and advancing a guidewirethrough the lumen of the elongate guide such that the guidewire extendsinto or through the natural paranasal sinus ostium, wherein theadvancing step further comprises advancing the balloon catheter over theguidewire to a position where the balloon is positioned within thenatural paranasal sinus ostium.
 23. A method according to claim 18wherein a distal end of the balloon catheter is bent or angled.
 24. Amethod according to claim 18 further comprising using an endoscope forvisualization.
 25. A method according to claim 18 further comprisingadvancing the balloon through a lumen of a stabilizing member.
 26. Amethod according to claim 18 wherein the natural paranasal sinus ostiumis a maxillary sinus ostium.
 27. A method according to claim 18 whereinthe natural paranasal sinus ostium is a frontal sinus ostium.
 28. Amethod according to claim 18 further comprising treating an ethmoidsinus.
 29. A method according to claim 18 wherein the balloon catheterhas at least one distance marking or marker band.
 30. A method accordingto claim 18 wherein the balloon comprises a cylindrical balloon having afirst end and a second end with a cylindrical surface therebetween, andwherein the inflation of the balloon within the natural paranasal sinusostium radially expands the cylindrical surface against the surroundingostium.
 31. A method according to claim 30 wherein a diameter of theinflated cylindrical balloon is sufficiently greater than a diameter ofthe natural paranasal sinus ostium.
 32. A method according to claim 18wherein the enlarging of the ostium, the deflating of the balloon, andthe removing of the balloon catheter are included in a procedureperformed while the patient is disposed in a clinical workingenvironment.
 33. A method according to claim 18 wherein the enlarging ofthe ostium is performed so that, after the deflating of the balloon andremoving of the balloon catheter and the elongate guide, outflow fromthe paranasal sinus is enhanced such that the sinusitis of the patientis mitigated.
 34. A method according to claim 18 wherein the enlargingof the ostium is performed so that, after the deflating of the balloonand removing of the balloon catheter and the elongate guide, drainage ofmucus from the paranasal sinus is enhanced such that the sinusitis ofthe patient is mitigated.